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NCT Number: NCT06660563

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)

The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord Hospital, Concord, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (β)-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

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

Treatment and study plan

JNJ-80948543

Drug

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

JNJ-75348780

Drug

JNJ-75348780 will be administered as SC injection.

Primary outcomes

  1. Number of Participants with Dose-limiting Toxicity (DLT)

    Time frame: Up to 1 year and 10 months

    Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2 bleeding; Grade 4 anemia).

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 1 year and 10 months

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Secondary outcomes

  1. Serum Concentration of JNJ-80948543 and JNJ-75348780

    Time frame: Up to 1 year and 10 months

    Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.

  2. Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780

    Time frame: Up to 1 year and 10 months

    AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.

  3. Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780

    Time frame: Up to 1 year and 10 months

    Cmax for JNJ-80948543 and JNJ-75348780 will be reported.

  4. Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780

    Time frame: Up to 1 year and 10 months

    Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780.

  5. Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780

    Time frame: Up to 1 year and 10 months

    Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed.

  6. Overall Response Rate (ORR)

    Time frame: Up to 1 year and 10 months

    ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria.

  7. Complete Response Rate (CRR)

    Time frame: Up to 1 year and 10 months

    CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria.

  8. Duration of Response (DoR)

    Time frame: Up to 1 year and 10 months

    DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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