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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05172596
Registration number
NCT05172596
Ethics application status
Date submitted
22/12/2021
Date registered
29/12/2021
Titles & IDs
Public title
PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
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Scientific title
A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.
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Secondary ID [1]
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2021-003747-22
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Secondary ID [2]
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CPHE885B12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - PHE885
Experimental: PHE885 - Patients will receive PHE885
Treatment: Other: PHE885
Intravenous (IV) infusion
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set
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Assessment method [1]
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Percentage of patients with best overall response (BOR) of either stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) according to the International Myeloma Working Group (IMWG) criteria'
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Timepoint [1]
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24 Months
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Secondary outcome [1]
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Key Secondary End point: MRD Negativity rate in Bone Marrow
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Assessment method [1]
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Evaluate the efficacy of PHE885 with respect to MRD negativity rate in bone marrow measured by next generation sequencing (NGS)
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Complete response rate (CRR)
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Assessment method [2]
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Percentage of patients with BOR of sCR or CR according to the IMWG criteria
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Timepoint [2]
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24 Months
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Secondary outcome [3]
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Time to response
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Assessment method [3]
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Time form PHE885 infusion to the date of first documented response (PR or better)
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Timepoint [3]
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24 Months
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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Time from first documented response (PR or better) until relapse or death due to any cause
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Timepoint [4]
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24 Months
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Secondary outcome [5]
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Progression free survival (PFS)
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Assessment method [5]
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Time from PHE885 infusion until progression or death due to any cause
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Timepoint [5]
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24 Months
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Secondary outcome [6]
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Time to next anti-myeloma treatment (TTNT)
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Assessment method [6]
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Time from PHE885 infusion until start of new anti-myeloma therapy or death due to any cause
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Timepoint [6]
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24 Months
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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Time from PHE885 infusion until death due to any cause
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Timepoint [7]
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24 Months
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Secondary outcome [8]
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Durability of Minimal Residual Disease (MRD)negativity
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Assessment method [8]
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Time from the start of undetectable MRD to the time of reappearance of detectable MRD
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Timepoint [8]
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24 Months
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Secondary outcome [9]
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Patient Reported Outcomes (PRO): EQ-5D-5L Health Questionnaire
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Assessment method [9]
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PROs as measured by EuroQoL Group EQ-5D-5L Health Questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Patient Reported Outcomes (PRO): EORTC-QLQ-C30
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Assessment method [10]
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PROs as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30) Questionnaire will be used as a measure of health-related quality of life.
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Timepoint [10]
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24 months
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Secondary outcome [11]
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Patient Reported Outcomes (PRO): EORTC-QLQ-MY20
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Assessment method [11]
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PROs as measured by EORTC-QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality.
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Timepoint [11]
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24 months
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Secondary outcome [12]
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PHE885 manufacturing success rate
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Assessment method [12]
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Percentage of enrolled patients for whom PHE885 product was manufactured that met all release specifications
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Timepoint [12]
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24 Months
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Secondary outcome [13]
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Manufacturing turnaround time
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Assessment method [13]
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Time from pick of cryopreserved material at the clinic or hospital until return to the clinical or hospital
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Timepoint [13]
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24 months
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Secondary outcome [14]
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Transgene of PHE885 concentrations over time in peripheral blood and bone marrow
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Assessment method [14]
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As determined by quantitative polymerase chain reaction (qPCR)
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Timepoint [14]
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24 Months
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Secondary outcome [15]
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Cellular kinetics parameter: Cmax
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Assessment method [15]
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The maximum transgene level at Tmax
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Timepoint [15]
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24 Months
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Secondary outcome [16]
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Cellular kinetics parameter: Tmax
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Assessment method [16]
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The time to peak transgene level
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Timepoint [16]
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24 Months
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Secondary outcome [17]
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Cellular kinetics parameter: AUC
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Assessment method [17]
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The Area under the curve of the transgene level
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Timepoint [17]
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24 months
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Secondary outcome [18]
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Immunogenicity to PHE885
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Assessment method [18]
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Summary of pre-existing and treatment-induced immunogenicity (cellular and humoral) of PHE885
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Timepoint [18]
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24 Months
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Eligibility
Key inclusion criteria
1. =18 years of age at the time of informed consent form (ICF) signature
2. Adult patients after failure of three or more lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and who have documented evidence of disease progression (IMWG criteria) 3, Must have received =2 consecutive cycles of treatment for at least three prior regimens unless deemed refractory to that regimen (i.e., progressive disease as the best response)
4. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1.Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific antibodies or anti-BCMA antibody drug conjugate.
3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing informed consent.
4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol.
Other protocol-defined Inclusion/Exclusion may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
146
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Recruitment in Australia
Recruitment state(s)
MelbourneNSW
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Recruitment hospital [1]
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Novartis Investigative Site - VIC
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Recruitment hospital [2]
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Novartis Investigative Site - Camperdown
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Recruitment postcode(s) [1]
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3004 - VIC
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Oregon
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Washington
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Country [7]
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Brazil
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State/province [7]
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BA
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Country [8]
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Brazil
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State/province [8]
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SP
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Country [9]
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Canada
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State/province [9]
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Alberta
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Country [10]
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France
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State/province [10]
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Lille
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Country [11]
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France
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State/province [11]
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Nantes Cedex 1
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Country [12]
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France
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State/province [12]
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Paris 10
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Country [13]
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France
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State/province [13]
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Poitiers
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Country [14]
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Germany
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State/province [14]
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Hamburg
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Country [15]
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Germany
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State/province [15]
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Heidelberg
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Country [16]
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Germany
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State/province [16]
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Koeln
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Country [17]
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Germany
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State/province [17]
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Wuerzburg
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Country [18]
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Greece
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State/province [18]
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GR
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Country [19]
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Greece
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State/province [19]
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Athens
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Country [20]
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Israel
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State/province [20]
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Ramat Gan
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Country [21]
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Israel
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State/province [21]
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Tel Aviv
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Country [22]
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Italy
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State/province [22]
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BO
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Country [23]
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Italy
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State/province [23]
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MI
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Country [24]
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Japan
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State/province [24]
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Aichi
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Japan
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State/province [25]
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Hokkaido
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Japan
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State/province [26]
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Kyoto
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Country [27]
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Japan
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State/province [27]
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Miyagi
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Country [28]
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Saudi Arabia
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State/province [28]
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Riyadh
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Country [29]
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Singapore
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State/province [29]
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Singapore
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Country [30]
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Spain
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State/province [30]
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Castilla Y Leon
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Country [31]
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Spain
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State/province [31]
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Navarra
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Country [32]
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United Kingdom
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State/province [32]
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Birmingham
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Country [33]
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United Kingdom
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State/province [33]
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be investigated as a single agent in relapsed and refractory multiple myeloma
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Trial website
https://clinicaltrials.gov/study/NCT05172596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The Trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05172596