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

NCT06139406 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 87801493LYM10012023-505165-93-00
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 12

Brief Summary

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 \[Part B: Dose Expansion\].

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

  Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity

  Up to 2 years 7 months

• Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity

  An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events \[ICANS\]).

  Up to 2 years 7 months

Secondary Outcomes (15)

• Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780

  Up to 2 years 7 months

• Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780

  Up to 2 years 7 months

• Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780

  Up to 2 years 7 months

• Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780

  Up to 2 years 7 months

• Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780

  Up to 2 years 7 months

Study Arms (2)

Part 1: Dose escalation

EXPERIMENTAL

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.

Drug: JNJ-87801493; Drug: JNJ-80948543; Drug: JNJ-75348780

Part 2:Dose expansion

EXPERIMENTAL

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

Drug: JNJ-87801493; Drug: JNJ-80948543; Drug: JNJ-75348780

Interventions

JNJ-87801493 DRUG

JNJ-87801493 will be administered subcutaneously.

Part 1: Dose escalation; Part 2:Dose expansion

JNJ-80948543 DRUG

JNJ-80948543 will be administered subcutaneously.

Part 1: Dose escalation; Part 2:Dose expansion

JNJ-75348780 DRUG

JNJ-75348780 will be administered subcutaneously.

Part 1: Dose escalation; Part 2:Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (12)

Austin Hospital

Heidelberg, 3084, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Linear Clinical Research Ltd

Nedlands, 6009, Australia

Location

Scientia Clinical Research

Randwick, 2031, Australia

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Sourasky (Ichilov) Medical Center

Tel Aviv, 6423906, Israel

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (1)

• Kuchnio A, Yang D, Vloemans N, Cornelissen I, Amorim R, Perova T, Lowenstein C, Janssen L, Suls T, Bekkers M, Lasorsa E, Fontan L, Nemani N, Hojnacki T, Han C, Sukumaran S, Medeiros N, Srinivasan S, Wu B, Chen J, Feldkamp MD, Wu S, Habte H, McRee AJ, Daskalakis N, Krayer J, Holland C, Attar R, DeYoung PM, Singh S, Elsayed Y, Philippar U. Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. Haematologica. 2026 Feb 26. doi: 10.3324/haematol.2025.288473. Online ahead of print.

  PMID: 41742895 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: December 6, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); DK (2); ES (4); IL (2)