JNJ-67856633 for Lymphoma and Leukemia

Recruiting at 61 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

226 Participants Needed

Trial Summary

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.

What makes the drug JNJ-67856633 unique for treating lymphoma and leukemia?

JNJ-67856633 is unique because it targets the JAK3 enzyme, which is involved in cell growth and survival pathways in leukemia cells. This specificity may offer a new approach compared to other treatments that do not target JAK3. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests JNJ-67856633, an oral drug, in patients with certain blood cancers that have returned or resisted treatment. The drug works by blocking a protein that helps cancer cells grow. The study aims to find the safest dose and see if the drug is effective.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Recent advances in JAK3 kinase inhibitors. [2005]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Expression of JL1 in Burkitt lymphoma is associated with improved overall survival. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

CD123 expression patterns and selective targeting with a CD123-targeted antibody-drug conjugate (IMGN632) in acute lymphoblastic leukemia. [2020]

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

Targetable vulnerabilities in T- and NK-cell lymphomas identified through preclinical models. [2022]