JNJ-64264681 + JNJ-67856633 for Chronic Lymphocytic Leukemia

No longer recruiting at 46 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: BTK inhibitors, MALT inhibitors

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: 1

Duration: Variable (up to 2 years and 2 months)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal doses and assess the safety of two new drugs, JNJ-64264681 and JNJ-67856633, for treating certain blood cancers, specifically B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Participants will receive these drugs to evaluate their combined effectiveness and potential side effects. Suitable candidates include those with chronic lymphocytic leukemia or B cell non-Hodgkin lymphoma who have not previously received these specific drugs. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new drugs.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-64264681 has not raised any major safety concerns in earlier studies. The choice of doses was based on safety and tolerability, indicating it is generally well-tolerated. Ongoing studies are examining the safety of using JNJ-64264681 and JNJ-67856633 together. These studies aim to understand the drugs' mechanisms in the body and patient reactions. Although this research remains in the early stages, no significant safety issues have been reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-64264681 and JNJ-67856633 for treating Chronic Lymphocytic Leukemia (CLL) because these drugs target specific proteins that help cancer cells survive. Unlike standard treatments like chemo or immunotherapy, these investigational drugs work by inhibiting Bruton's tyrosine kinase (BTK) and another protein that helps cancer cells evade death. This approach could offer a more precise attack on cancer cells, potentially leading to fewer side effects and improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?

Research has shown that the combination of two drugs, JNJ-64264681 and JNJ-67856633, holds strong potential in fighting cancer cells. Lab studies demonstrated this combination's effectiveness against certain types of diffuse large B-cell lymphoma (DLBCL), a form of non-Hodgkin lymphoma. These studies suggest that using both drugs together can enhance the body's ability to fight tumors, indicating they might work better as a pair. This trial will evaluate the effectiveness of this combination in participants with chronic lymphocytic leukemia (CLL). Early results from these tests offer hope that this treatment could also benefit people with CLL and similar cancers. ^{1 2 3 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trials

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with certain types of blood cancers, like Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), have a specific heart rhythm measurement within normal limits, and women must use effective contraception. People who've had previous treatments with the study drugs or certain other cancer therapies can't join.

Inclusion Criteria

I have B cell non-Hodgkin lymphoma and my tumor tissue is available for testing.

Cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Received prior solid organ transplantation

My cancer has spread to my brain or spinal cord.

I have previously been treated with JNJ 64264681 or JNJ-67856633, or stopped a BTK/MALT inhibitor without bad side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive JNJ-64264681 and JNJ-67856633 in 21-day cycles until disease progression, intolerable toxicity, or withdrawal

Variable (up to 2 years and 2 months)

Regular visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years and 9 months

Periodic visits

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-64264681
• JNJ-67856633

Trial Overview The trial is testing two drugs, JNJ-64264681 and JNJ-67856633, to find safe doses when used together in patients with B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has two parts: dose finding (Part A) and checking safety across different patient groups (Part B).

How Is the Trial Designed?

Group I: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633 Experimental Treatment 2 Interventions

Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Group II: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633 Experimental Treatment 2 Interventions

Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator.

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/NCT04657224?term=JNJ-64264681&viewType=Table&rank=3

NCT04657224 | A Study of JNJ-64264681 and ... The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in ...

2. trial.medpath.com trial.medpath.com/clinical-trial/0536406ad83cdbae/nct04657224-safety-pharmacokinetics-jnj-64264681-jnj-67856633-non-hodgkin-lymphoma-chronic

A Study of JNJ-64264681 and JNJ-67856633 in Participants ... The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in ...

3. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/52350/pdf

A Phase 1b, Open-Label Study of the Strong synergistic effects of the. JNJ-64264681 and JNJ-67856633 combination were observed in 3 DLBCL cell lines carrying CD79b mutations and 1 ...

4. veri.larvol.com veri.larvol.com/news/jnj-64264681/drug

News - JNJ-4681 Taken together, the in vitro and in vivo data for JNJ‑67856633 and JNJ-64264681 suggest that combination therapy can increase the anti-tumor effect of the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03900598

NCT03900598 | A Study of JNJ-67856633 in Participants ... The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed/ ...

6. isrctn.com isrctn.com/ISRCTN87946208

A rollover study for continued study treatment and ongoing ... This study will be conducted as a continuous safety monitoring of the active study treatment for drugs (JNJ-64264681, JNJ-67856633 [safimaltib], and JNJ- ...