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Testing a new antibody for treating certain blood cancers

A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

Phase 1 Interventional Janssen Research & Development, LLC · NCT05424822

This study is testing a new antibody treatment for people with certain types of blood cancers who have run out of other options to see if it is safe and effective.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsCAR-T, chemotherapy, methotrexate
Locations29 sites (Duarte, California and 28 other locations)
Trial IDNCT05424822 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and optimal dosing of JNJ-80948543, a trispecific antibody designed to target B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. It consists of two parts: a dose escalation phase to determine the recommended Phase 2 doses and an expansion phase to further assess safety at those doses. Participants will be those with relapsed or refractory disease who have no other approved treatment options available. The study aims to provide insights into the effectiveness of this novel therapy.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia who require therapy.

Not a fit: Patients with early-stage disease or those who have not yet received treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies involving trispecific antibodies have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.

All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.

B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:

If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.

If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.

If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.

If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .

Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.

small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria

* Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
* Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula \[QTcF\]) less than or equal to (\<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus \[+-\] 3) minutes apart
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment
* A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment

Exclusion Criteria:

* Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
* 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, particularly the need for supplemental oxygen use to maintain adequate oxygenation

Where this trial is running

Duarte, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.