JNJ-80948543 for Lymphoma and Leukemia

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Janssen Research & Development, LLC

Must not be taking: Systemic steroids

Disqualifiers: CNS involvement, Organ transplant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests JNJ-80948543, a new medicine that helps the immune system fight B-cell non-Hodgkin lymphoid malignancies. It works by connecting immune cells to cancer cells, aiding in their destruction. The study aims to find the best dose and schedule while monitoring safety and effectiveness over an extended period.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroids or other immunosuppressive agents, you may not be eligible to participate.

What data supports the effectiveness of the treatment JNJ-80948543 for Lymphoma and Leukemia?

Research on similar trispecific antibodies, like the CD3/CD19/CD20 trispecific antibody, shows they can effectively recruit T cells to target and kill cancer cells, suggesting potential for JNJ-80948543 in treating leukemia and lymphoma. ^{1 2 3 4 5}

What makes the drug JNJ-80948543 unique for treating lymphoma and leukemia?

JNJ-80948543 is a trispecific antibody that targets CD79b, CD20, and CD3, which allows it to engage T cells to attack cancer cells more effectively. This approach is novel because it can target multiple antigens on cancer cells, potentially overcoming resistance seen with other treatments that target only one or two antigens. ^{1 2 3 4 6}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia who need treatment and have tried other therapies without success. They should be in good physical condition (ECOG Grade 0 or 1) and not pregnant, breastfeeding, or planning pregnancy soon. People with active brain involvement by cancer, recent organ transplants, autoimmune diseases needing strong medication within the last year, unresolved side effects from previous treatments (except certain stable conditions), or significant lung problems are excluded.

Inclusion Criteria

My lymphoma meets specific criteria for the trial.

I am a woman who can have children, not pregnant, and agree to regular pregnancy tests.

I am fully active or can carry out light work.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I haven't taken steroids or immunosuppressants for my autoimmune disease in the last year.

I need extra oxygen to breathe properly.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-80948543 to determine the recommended Phase 2 dose, dosing schedule, and route of administration based on safety and preliminary efficacy

Up to 4 Years 3 months

Cohort Expansion

Participants receive JNJ-80948543 at the recommended Phase 2 dose to further characterize safety

Up to 4 Years 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JNJ-80948543 (Monoclonal Antibodies)

Trial Overview The study tests JNJ-80948543, a new type of antibody designed to target cancer cells in two phases: first to find the safest dose (Part A) and then to confirm its safety at that dose in more people (Part B). It's given to patients whose disease has returned after treatment or hasn't responded well to existing options.

Participant Groups

Group I: Part B: Cohort Expansion Experimental Treatment 1 Intervention

Participants will receive JNJ-80948543 by SC or IV administration.

Group II: Part A: Dose Escalation Experimental Treatment 1 Intervention

Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

The study developed trispecific antibodies that can engage T cells and target tumor cells, showing that certain combinations of T cell receptor (TCR) and accessory molecules can enhance T cell activation and tumor cell lysis.

Two groups of trispecific antibodies were identified: one group showed minimal cytotoxicity despite effective T cell activation, while another group demonstrated high cytotoxicity against tumor cells, suggesting that the signals required for T cell proliferation differ from those needed for effective tumor lysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trispecific F(ab')3 derivatives that use cooperative signaling via the TCR/CD3 complex and CD2 to activate and redirect resting cytotoxic T cells. Tutt, A., Stevenson, GT., Glennie, MJ.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mono- and dual-targeting triplebodies activate natural killer cells and have anti-tumor activity in vitro and in vivo against chronic lymphocytic leukemia. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Preclinical characterization and comparison between CD3/CD19 bispecific and novel CD3/CD19/CD20 trispecific antibodies against B-cell acute lymphoblastic leukemia: targeted immunotherapy for acute lymphoblastic leukemia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Trispecific F(ab')3 derivatives that use cooperative signaling via the TCR/CD3 complex and CD2 to activate and redirect resting cytotoxic T cells. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Rejuvenation of tumour-specific T cells through bispecific antibodies targeting PD-L1 on dendritic cells. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dancing partners at the ball: Rational selection of next generation anti-CD20 antibodies for combination therapy of chronic lymphocytic leukemia in the novel agents era. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. [2021]