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A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer

NCT ID: NCT06139406

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2026-08-31

Brief Summary

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The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) \[Part A: Dose Escalation\] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs \[Part B: Dose Expansion\].

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose escalation

Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later.

Group Type EXPERIMENTAL

JNJ-87801493

Intervention Type DRUG

JNJ-87801493 will be administered subcutaneously.

JNJ-80948543

Intervention Type DRUG

JNJ-80948543 will be administered subcutaneously.

JNJ-75348780

Intervention Type DRUG

JNJ-75348780 will be administered subcutaneously.

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.

Group Type EXPERIMENTAL

JNJ-87801493

Intervention Type DRUG

JNJ-87801493 will be administered subcutaneously.

JNJ-80948543

Intervention Type DRUG

JNJ-80948543 will be administered subcutaneously.

JNJ-75348780

Intervention Type DRUG

JNJ-75348780 will be administered subcutaneously.

Interventions

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JNJ-87801493

JNJ-87801493 will be administered subcutaneously.

Intervention Type DRUG

JNJ-80948543

JNJ-80948543 will be administered subcutaneously.

Intervention Type DRUG

JNJ-75348780

JNJ-75348780 will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
* Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
* 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 (β)-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.

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 2 weeks 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Austin Hospital

Heidelberg, , Australia

Site Status

The Alfred Hospital

Melbourne, , Australia

Site Status

Linear Clinical Research Ltd

Nedlands, , Australia

Site Status

Scientia Clinical Research

Randwick, , Australia

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Sourasky (Ichilov) Medical Center

Tel Aviv, , Israel

Site Status

Hosp Univ Vall D Hebron

Barcelona, , Spain

Site Status

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Countries

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Australia Denmark Israel Spain

Other Identifiers

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87801493LYM1001

Identifier Type: -

Identifier Source: org_study_id

87801493LYM1001

Identifier Type: OTHER

Identifier Source: secondary_id

2023-505165-93-00

Identifier Type: REGISTRY

Identifier Source: secondary_id