Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04540796
Registration number
NCT04540796
Ethics application status
Date submitted
2/09/2020
Date registered
7/09/2020
Titles & IDs
Public title
A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Query!
Scientific title
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL
Query!
Secondary ID [1]
0
0
2020-001183-29
Query!
Secondary ID [2]
0
0
CR108882
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin
0
0
Query!
Leukemia, Lymphocytic, Chronic, B-Cell
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-75348780
Experimental: Part A: Dose Escalation - Participants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.
Experimental: Part B: Cohort Expansion - Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.
Treatment: Drugs: JNJ-75348780
Participants will receive JNJ-75348780 by subcutaneous (SC) administration.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Query!
Assessment method [1]
0
0
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Query!
Timepoint [1]
0
0
Up to 2 years 10 months
Query!
Primary outcome [2]
0
0
Part A and Part B: Number of Participants with AEs by Severity
Query!
Assessment method [2]
0
0
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Query!
Timepoint [2]
0
0
Up to 2 years 10 months
Query!
Primary outcome [3]
0
0
Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT)
Query!
Assessment method [3]
0
0
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Query!
Timepoint [3]
0
0
Up to 28 days
Query!
Secondary outcome [1]
0
0
Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780
Query!
Assessment method [1]
0
0
AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.
Query!
Timepoint [1]
0
0
Up to 2 years 10 months
Query!
Secondary outcome [2]
0
0
Maximum Observed Serum Concentration (Cmax) of JNJ-75348780
Query!
Assessment method [2]
0
0
Cmax is the maximum observed serum concentration of JNJ-75348780.
Query!
Timepoint [2]
0
0
Predose, 48 hours postdose (up to 2 years 10 months)
Query!
Secondary outcome [3]
0
0
Minimum Observed Serum Concentration (Cmin) of JNJ-75348780
Query!
Assessment method [3]
0
0
Cmin is the minimum observed serum concentration of JNJ-75348780.
Query!
Timepoint [3]
0
0
Predose, 48 hours postdose (up to 2 years 10 months)
Query!
Secondary outcome [4]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [4]
0
0
ORR is defined as the percentage of participants who achieve a partial response (PR) or better according to the revised response criteria for malignant lymphoma, the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) response criteria.
Query!
Timepoint [4]
0
0
Up to 2 years 10 months
Query!
Secondary outcome [5]
0
0
Complete Response (CR) Rate
Query!
Assessment method [5]
0
0
CR rate is defined as the percentage of participants who achieve a best response of CR according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Query!
Timepoint [5]
0
0
Up to 2 years 10 months
Query!
Secondary outcome [6]
0
0
Time to Response (TTR)
Query!
Assessment method [6]
0
0
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Query!
Timepoint [6]
0
0
Up to 2 years 10 months
Query!
Secondary outcome [7]
0
0
Duration of Response (DOR)
Query!
Assessment method [7]
0
0
DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Query!
Timepoint [7]
0
0
Up to 2 years 10 months
Query!
Eligibility
Key inclusion criteria
* Histologic documentation of disease: B-cell NHL or CLL requiring therapy; All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. B cell NHL as defined per the 2016 World Health Organization (WHO) classification: In addition, the following disease-specific criteria outlined below must be met a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue [MALT]), or Waldenstrom macroglobulinemia (WM): previously treated with a minimum of 2 prior lines of systemic therapy, with at least 1 prior line containing an anti-CD20 antibody, c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 2 prior lines of therapy to include a bruton tyrosine kinase inhibitor (BTKi) and/or a B-cell lymphoma (BCL)2 inhibitor, if eligible. For Part B: participants must have measurable disease as defined by the appropriate disease response criteria
* Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
* Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds (ms) based on the average of triplicate assessments performed no more than 5 (plus minus [+ -] 3) minutes apart
* Women of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug
* Women must be: a) not of childbearing potential, b) of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 90 days after last dose
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known central nervous system (CNS) involvement with lymphoma
* Prior solid-organ transplantation
* Either of the following: a) received an autologous stem cell transplant <=3 months before the first dose of JNJ 75348780, b) prior treatment with allogenic stem cell transplant <= 6 months before the first dose of JNJ-75348780, or has evidence of graft versus host disease that requires immunosuppressant therapy
* Prior chemotherapy, targeted therapy, immunotherapy or radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), within 2 weeks before the first administration of study drug. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives, whichever is longer. For investigational agents with long half-lives a wash-out of 4 weeks is acceptable. Participants who received prior treatment with anti-CD20 * anti-CD3 bispecific therapy will be excluded until a dedicated cohort(s) is opened as determined by the SET
* Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus)
* History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 1 year before the first dose of study drug. Concomitant malignancies that are unlikely to progress and/or preclude evaluation of study endpoints may be allowed after discussion with the Study Responsible Physician
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/11/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
9/05/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
147
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [2]
0
0
Linear Clinical Research Ltd - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New York
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Texas
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Lille
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
NANTES Cedex 1
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Pierre Benite
Query!
Country [7]
0
0
Israel
Query!
State/province [7]
0
0
Haifa
Query!
Country [8]
0
0
Israel
Query!
State/province [8]
0
0
Jerusalem
Query!
Country [9]
0
0
Israel
Query!
State/province [9]
0
0
Ramat Gan
Query!
Country [10]
0
0
Israel
Query!
State/province [10]
0
0
Tel Aviv
Query!
Country [11]
0
0
Korea, Republic of
Query!
State/province [11]
0
0
Seoul
Query!
Country [12]
0
0
Spain
Query!
State/province [12]
0
0
Barcelona
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Madrid
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Pamplona
Query!
Country [15]
0
0
Spain
Query!
State/province [15]
0
0
Salamanca
Query!
Country [16]
0
0
Taiwan
Query!
State/province [16]
0
0
Kaohsiung
Query!
Country [17]
0
0
Taiwan
Query!
State/province [17]
0
0
Taichung
Query!
Country [18]
0
0
Taiwan
Query!
State/province [18]
0
0
Tainan
Query!
Country [19]
0
0
Taiwan
Query!
State/province [19]
0
0
Taipei
Query!
Country [20]
0
0
United Kingdom
Query!
State/province [20]
0
0
Leicester
Query!
Country [21]
0
0
United Kingdom
Query!
State/province [21]
0
0
London
Query!
Country [22]
0
0
United Kingdom
Query!
State/province [22]
0
0
Manchester
Query!
Country [23]
0
0
United Kingdom
Query!
State/province [23]
0
0
Plymouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04540796
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
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/NCT04540796