JNJ-75348780 for Lymphoma and Leukemia

Recruiting at 53 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Anti-CD20 antibody

Must not be taking: Immunosuppressive medications

Disqualifiers: CNS involvement, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests JNJ-75348780, a new medicine that helps the immune system fight blood cancers in patients whose cancers have returned or did not respond to other treatments. It works by connecting immune cells to cancer cells, helping the immune system attack the cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 2 weeks before starting the study drug. If you are on investigational agents, a treatment-free window of at least 2 weeks or 5 half-lives is required, whichever is longer.

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 that's come back or hasn't responded to treatment. They should have tried other approved treatments without success and must not be pregnant, agree to use effective contraception, and be in good physical condition (ECOG Grade 0 or 1).

Inclusion Criteria

Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds (ms) based on the average of triplicate assessments performed no more than 5 (plus minus [+ -] 3) minutes apart

Women of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug

Histologic documentation of disease: B-cell NHL or 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 a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue [MALT]), or Waldenstrom macroglobulinemia (WM): previously treated with a minimum of 2 prior lines of systemic therapy, with at least 1 prior line containing an anti-CD20 antibody, c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 2 prior lines of therapy to include a bruton tyrosine kinase inhibitor (BTKi) and/or a B-cell lymphoma (BCL)2 inhibitor, if eligible. For Part B: participants must have measurable disease as defined by the appropriate disease response criteria

Exclusion Criteria

I had a stem cell transplant recently or need immunosuppressants due to graft versus host disease.

I haven't had cancer, other than skin or cervical cancer, in the last year.

I haven't had cancer treatments excluding minor radiation, for at least 2 weeks or 5 half-lives of the drug, whichever is longer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part A: Dose Escalation

Participants receive JNJ-75348780 with dose levels escalated sequentially to determine the recommended Phase 2 dose(s)

Up to 28 days

Treatment - Part B: Cohort Expansion

Participants receive JNJ-75348780 at one of the recommended Phase 2 doses determined in Part A

Up to 2 years 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years 10 months

Treatment Details

Interventions

• JNJ-75348780

Trial Overview The study tests JNJ-75348780's safety and optimal dose for patients with specific types of lymphomas and leukemia. Part A determines the best dose while Part B further examines its safety at this established dose.

Participant Groups

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

Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.

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

Participants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.

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