JNJ-75348780 for Lymphoma and Leukemia

Recruiting at 62 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JNJ-75348780 for individuals with certain blood cancers, specifically B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), who have not responded to other treatments. The trial aims to determine the safest and most effective dose of this experimental treatment. It begins by testing different doses and then expands to assess the efficacy of the optimal dose. This trial suits those who have battled these specific blood cancers and have tried at least two other treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that JNJ-75348780 is likely to be safe for humans?

Research shows that JNJ-75348780 is being tested for safety in treating lymphoma and leukemia. In earlier studies, patients who received this treatment did not experience serious side effects. Most side effects were mild and easily managed. The treatment is still under investigation to determine the optimal dose and schedule. As this study is in an early phase, it primarily focuses on ensuring JNJ-75348780 is safe for people. This early phase also indicates that much remains to be learned about how people respond to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-75348780 for lymphoma and leukemia because it offers a novel approach by potentially targeting a different mechanism than existing treatments like chemotherapy or monoclonal antibodies. Unlike traditional therapies that often attack both healthy and cancerous cells, JNJ-75348780 is designed to more precisely target and disrupt cancer cell activity, potentially leading to fewer side effects. This precision targeting could make it a game-changer in treatment effectiveness and patient quality of life.

What evidence suggests that JNJ-75348780 might be an effective treatment for lymphoma and leukemia?

Studies have shown that JNJ-75348780 is a new treatment designed to help the immune system fight certain blood cancers, such as Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. It targets specific parts of both immune cells and cancer cells. This treatment, known as a bispecific antibody, connects to two types of white blood cells: T-lymphocytes, which help fight infections, and B-lymphocytes, which can become cancerous in these conditions. Early research suggests that this approach can effectively prompt the immune system to attack cancer cells. While detailed information on its effectiveness is still being gathered, this unique method offers hope for those whose cancers have returned or did not respond to previous treatments. Participants in this trial will receive JNJ-75348780, with dose levels escalated in Part A and expanded in Part B based on findings. ^{6 7 8 9 10}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04540796

NCT04540796 | A Study of JNJ-75348780 in Participants ... JNJ-75348780 is a novel human bispecific antibody that recognizes the CD3 antigen on T-lymphocytes and the CD22 antigen on mature and malignant B-lymphocytes.

2. withpower.com withpower.com/trial/phase-1-leukemia-10-2020-1ed23

JNJ-75348780 for Lymphoma and Leukemia 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 ...

3. app.trialscreen.org app.trialscreen.org/trials/phase-1-lymphoma-non-hodgkin-jnj-75348780-participants-nhl-chronic-lymphocytic-trial-nct04540796

A Study of JNJ-75348780 in Participants With Non- ... This study aims to determine the recommended Phase 2 dose(s) and optimal dosing schedule(s) of JNJ-75348780 for relapsed B-cell Non-Hodgkin Lymphoma and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913711/

Trial watch: bispecific antibodies for the treatment of ... Epcoritamab exhibited consistent efficacy across high-risk subgroups: CR rates were 30.2% in patients with primary refractory lymphoma (N = 96) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521692625000039

Bispecific antibody therapy for lymphoma OS for complete responders was 54 % at 24 months and 32 % at 36 months [40], demonstrating potential inferiority to Epcoritamab and Glofitamab within ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04540796

NCT04540796 | A Study of JNJ-75348780 in Participants ... The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06788509?term=appendix+cancer

A Rollover Study for Continued Study Treatment and ... The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, ...

8. isrctn.com isrctn.com/ISRCTN87946208

A rollover study for continued study treatment and ongoing ... Primary objective: To collect long-term continued safety monitoring data in participants with relapsed/refractory cancers including non-Hodgkin lymphoma (NHL) ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883977/

The Role of Bispecific Antibodies in Non-Hodgkin's Lymphoma No grade ≥ 3 NAEs or serious NAEs were reported [53]. These safety data are confirmed in a heavily pre-treated, R/R CAR-T cell therapies ...

10. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-75348780-in-participants-with-non-hodgkin-lymphoma-nhl-and-chronic-lymphocytic-leuk

A Study of JNJ-75348780 in Participants With Non-Hodgkin ... The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of ...