JNJ-67856633 for Lymphoma and Leukemia

No longer recruiting at 72 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: MALT1 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: Unknown

Duration: Up to 4 years and 11 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, JNJ-67856633, to determine the optimal dose for treating certain blood cancers, specifically relapsed or hard-to-treat B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. The study evaluates participants' tolerance to the drug and its impact on their cancer. Individuals with these conditions who have not responded well to other treatments might be suitable candidates for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, providing an opportunity to be among the first to receive this new drug.

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

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

Is there any evidence suggesting that JNJ-67856633 is likely to be safe for humans?

Research has shown that JNJ-67856633 is generally safe for people. Studies have not identified any new safety issues, indicating that the treatment did not cause unexpected serious side effects. Although the treatment remains under investigation, early results suggest promising safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for lymphoma and leukemia, which often involves chemotherapy and targeted therapies like rituximab, JNJ-67856633 is unique because it targets different pathways in the cancer cells. Researchers are excited about JNJ-67856633 because it uses a novel mechanism of action that disrupts specific proteins involved in cancer cell survival and proliferation. This targeted approach not only aims to be more effective but also potentially reduces the side effects associated with traditional treatments.

What evidence suggests that JNJ-67856633 might be an effective treatment for lymphoma and leukemia?

Research shows that JNJ-67856633 may help treat various types of lymphomas, including both slow-growing and aggressive forms. Early studies have demonstrated that this treatment can affect cancer in some patients. In this trial, participants will receive JNJ-67856633, which is also being tested with BTK inhibitors in other studies, as these drugs can help when tumors do not respond to other treatments. Some early results suggest that JNJ-67856633 might increase the number of patients whose cancer shrinks or disappears after treatment. These findings support further research into JNJ-67856633 for treating B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia that have returned or are not responding to treatment. ^{1 2 3 6 7}

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 certain types of blood cancer, like Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia that has come back or didn't respond to treatment. They should have a heart rhythm within normal limits and be able to do most daily activities on their own. Women must test negative for pregnancy and both men and women need to use reliable birth control.

Inclusion Criteria

I will use a condom during sex, and my partner may use birth control too.

I am using a highly effective birth control method plus a condom.

Women of childbearing potential must have a negative highly sensitive serum (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug, and until 30 days after the last dose

Exclusion Criteria

I have been treated with a MALT1 inhibitor before.

I haven't had cancer, other than my current type, in the last year.

My brain or spinal cord cancer has been evaluated by the study team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or decision by investigator or sponsor

Up to 4 years and 11 months

Post-treatment

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-67856633

Trial Overview The study is testing the safety and best dose of a new drug called JNJ-67856633 in patients whose blood cancers have returned after treatment or haven’t responded at all. The goal is to find the highest dose patients can take without too many side effects.

How Is the Trial Designed?

Group I: Part 2 (Cohort Expansion): JNJ-67856633 Experimental Treatment 1 Intervention

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

Group II: Part 1 (Dose Escalation): JNJ-67856633 Experimental Treatment 1 Intervention

Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

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

Published Research Related to This Trial

CD123 is highly expressed in B acute lymphoblastic leukemia/lymphoma, with 89.6% of patients showing expression, making it a potential target for therapies like IMGN632.

IMGN632, a CD123-targeted antibody-drug conjugate, showed strong cytotoxic effects in vitro, eliminating over 90% of B acute lymphoblastic leukemia/lymphoma blasts at low concentrations while sparing normal lymphocytes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD123 expression patterns and selective targeting with a CD123-targeted antibody-drug conjugate (IMGN632) in acute lymphoblastic leukemia. Angelova, E., Audette, C., Kovtun, Y., et al.[2020]

In a mouse model of Philadelphia chromosome-positive acute lymphoblastic leukemia, the combination of dasatinib (targeting BCR-ABL kinase) and ruxolitinib (targeting JAK2) led to prolonged survival.

This combined treatment approach also helped prevent resistance to therapy, suggesting a promising strategy for improving outcomes in patients with this type of leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting BCR-ABL and JAK2 in Ph+ ALL. Hantschel, O.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10429444/

P624: PHASE 1 STUDY OF JNJ-67856633, A FIRST-IN- ... Results: At a clinical cutoff of January 22, 2023, 109 pts with R/R B-NHL or CLL received JNJ-67856633 (n=89, capsules; n=20, tablets). Median age was 70.0 ...

2. 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/ ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hon.3163_88

PHASE 1 STUDY OF JNJ‐67856633, A FIRST‐IN‐HUMAN ... JNJ-6633 demonstrated clinical activity in indolent and aggressive lymphomas. LD may be associated with higher ORR and is further explored in expansion cohorts.

4. aacrjournals.org aacrjournals.org/cancerres/article/80/16_Supplement/5690/644154/Abstract-5690-Discovery-of-JNJ-67856633-A-novel

Abstract 5690: Discovery of JNJ-67856633: A novel, first-in ... JNJ-67856633 is a combination partner for BTK inhibitors and a promising treatment option for BTKi-resistant tumors, with demonstrated ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03900598?cond=%22Chronic+lymphocytic+leukemia%22&aggFilters=status%3Acom

A Study of JNJ-67856633 in Participants With Non- ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

6. orpha.net orpha.net/en/research-trials/clinical-trial/610344?name=&mode=&country=&recruiting=0&terminated=0

A Study of JNJ-67856633 in Participants with Non- ... A Study of JNJ-67856633 in Participants with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) -JP ... Safety, Pharmacokinetics, and ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-64264681-and-jnj-67856633-in-participants-with-non-hodgkin-lymphoma-and-chronic-lymph

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.