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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06660563




Registration number
NCT06660563
Ethics application status
Date submitted
25/10/2024
Date registered
28/10/2024

Titles & IDs
Public title
A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
Scientific title
A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
Secondary ID [1] 0 0
80948543LYM1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-80948543
Treatment: Drugs - JNJ-75348780

Experimental: JNJ-80948543 - Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780.


Treatment: Drugs: JNJ-80948543
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.

Treatment: Drugs: JNJ-75348780
JNJ-75348780 will be administered as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to 1 year and 10 months
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to 1 year and 10 months
Secondary outcome [1] 0 0
Serum Concentration of JNJ-80948543 and JNJ-75348780
Timepoint [1] 0 0
Up to 1 year and 10 months
Secondary outcome [2] 0 0
Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780
Timepoint [2] 0 0
Up to 1 year and 10 months
Secondary outcome [3] 0 0
Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780
Timepoint [3] 0 0
Up to 1 year and 10 months
Secondary outcome [4] 0 0
Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780
Timepoint [4] 0 0
Up to 1 year and 10 months
Secondary outcome [5] 0 0
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780
Timepoint [5] 0 0
Up to 1 year and 10 months
Secondary outcome [6] 0 0
Overall Response Rate (ORR)
Timepoint [6] 0 0
Up to 1 year and 10 months
Secondary outcome [7] 0 0
Complete Response Rate (CRR)
Timepoint [7] 0 0
Up to 1 year and 10 months
Secondary outcome [8] 0 0
Duration of Response (DoR)
Timepoint [8] 0 0
Up to 1 year and 10 months

Eligibility
Key inclusion criteria
* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
* Participants must have measurable disease as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
* Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (ß)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known active central nervous system involvement (CNS) or leptomeningeal involvement
* Prior solid-organ transplantation
* Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
* Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
* Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
* Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/09/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Macquarie University Hospital - North Ryde
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona
Country [2] 0 0
Spain
State/province [2] 0 0
Madrid
Country [3] 0 0
Taiwan
State/province [3] 0 0
Taichung
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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/NCT06660563