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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06139406




Registration number
NCT06139406
Ethics application status
Date submitted
15/11/2023
Date registered
18/11/2023

Titles & IDs
Public title
A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
Scientific title
A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)
Secondary ID [1] 0 0
2023-505165-93-00
Secondary ID [2] 0 0
87801493LYM1001
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-87801493
Treatment: Drugs - JNJ-80948543
Treatment: Drugs - JNJ-75348780

Experimental: Part 1: Dose escalation - Participants will receive one cycle of TCE monotherapy (step up to target dose) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 one week later.

Experimental: Part 2:Dose expansion - Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1.


Treatment: Drugs: JNJ-87801493
JNJ-87801493 will be administered subcutaneously.

Treatment: Drugs: JNJ-80948543
JNJ-80948543 will be administered subcutaneously.

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

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Timepoint [1] 0 0
Up to 2 years 7 months
Primary outcome [2] 0 0
Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Up to 2 years 7 months
Secondary outcome [1] 0 0
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [1] 0 0
Up to 2 years 7 months
Secondary outcome [2] 0 0
Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [2] 0 0
Up to 2 years 7 months
Secondary outcome [3] 0 0
Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [3] 0 0
Up to 2 years 7 months
Secondary outcome [4] 0 0
Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [4] 0 0
Up to 2 years 7 months
Secondary outcome [5] 0 0
Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [5] 0 0
Up to 2 years 7 months
Secondary outcome [6] 0 0
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [6] 0 0
Up to 2 years 7 months
Secondary outcome [7] 0 0
Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [7] 0 0
Up to 2 years 7 months
Secondary outcome [8] 0 0
Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [8] 0 0
Up to 2 years 7 months
Secondary outcome [9] 0 0
Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Timepoint [9] 0 0
Up to 2 years 7 months
Secondary outcome [10] 0 0
Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
Timepoint [10] 0 0
Up to 2 years 7 months
Secondary outcome [11] 0 0
Overall Response as Assessed by the Investigator
Timepoint [11] 0 0
Up to 2 years 7 months
Secondary outcome [12] 0 0
Complete Response (CR) as Assessed by the Investigator
Timepoint [12] 0 0
Up to 2 years 7 months
Secondary outcome [13] 0 0
Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
Timepoint [13] 0 0
Up to 2 years 7 months
Secondary outcome [14] 0 0
Time to Response (TTR) as Assessed by the Investigator
Timepoint [14] 0 0
Up to 2 years 7 months
Secondary outcome [15] 0 0
Duration of Response (DOR) as Assessed by the Investigator
Timepoint [15] 0 0
Up to 2 years 7 months

Eligibility
Key inclusion criteria
* Histologic documentation of B-cell NHL. All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment
* Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease;all as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* 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 72 hours of 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. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
* Prior solid-organ transplantation
* Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
* Chemotherapy, targeted therapy, or immunotherapy within 14 days before the first dose of study treatment. 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. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
* Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
* Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
* Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
* Abnormal cardiac function

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
6/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/07/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment hospital [4] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
Israel
State/province [3] 0 0
Jerusalem
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Aviv
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid
Country [7] 0 0
Spain
State/province [7] 0 0
Pamplona
Country [8] 0 0
Spain
State/province [8] 0 0
Salamanca

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/NCT06139406