JNJ-64264681 for Non-Hodgkin's Lymphoma and Leukemia

No longer recruiting at 17 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: CNS involvement, Organ transplant, Allergies, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called JNJ-64264681 for individuals with B cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. The main goal is to determine a safe and effective dose for future studies and assess the drug's safety. Participants will take this experimental medication in capsule form, with doses adjusted based on early results. It suits those who have either condition and can perform daily activities without illness-related restrictions. As a Phase 1 trial, this research aims to understand 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 information does not specify if you need to stop taking your current medications. However, if you are on an investigational drug, you must stop it at least two weeks before starting the study drug.

Is there any evidence suggesting that JNJ-64264681 is likely to be safe for humans?

Research shows that JNJ-64264681 underwent safety testing in a study with healthy volunteers for up to 10 days. In these tests, most participants tolerated the treatment well, experiencing no serious side effects.

Animal studies have demonstrated that JNJ-64264681 can be used safely for up to one month. Although these studies differ from human tests, they offer clues about potential effects in people.

JNJ-64264681 is a BTK inhibitor, targeting a specific part of B cells, a type of white blood cell, to help combat diseases like certain lymphomas and leukemias.

This trial, being in an early phase, focuses on ensuring safety and determining the correct dose. Early-phase trials typically involve close monitoring to track side effects. Data from earlier studies suggest that JNJ-64264681 is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-64264681 because it represents a novel approach for treating Non-Hodgkin's Lymphoma and Leukemia. Unlike standard treatments like chemotherapy and monoclonal antibodies, JNJ-64264681 is an oral medication, which could potentially offer more convenience and better quality of life for patients. It works by targeting specific pathways involved in cancer cell growth, providing a more precise attack on cancer cells with potentially fewer side effects. This new mechanism of action is what makes it a promising candidate and a focus of current research efforts.

What evidence suggests that JNJ-64264681 might be an effective treatment for non-Hodgkin's lymphoma and leukemia?

Research is investigating the effectiveness of JNJ-64264681 for treating B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). This drug targets specific proteins on cancer cells to potentially halt or slow their growth. Early results suggest promise, but further information is necessary for confirmation. In this trial, participants will receive JNJ-64264681 in a dose escalation and expansion study to identify the optimal dose for future studies. While results appear hopeful, additional research will determine its true effectiveness for these conditions. ^{1 2 6 7 8}

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 cancers, like Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), able to follow the study rules, and have normal heart rhythm readings. Women must test negative for pregnancy and agree not to donate eggs during the study.

Inclusion Criteria

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

Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)

Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration

Exclusion Criteria

I haven't taken any experimental drugs or vaccines within the last 2 weeks or five half-lives before starting the study drug.

Participant has received prior solid organ transplantation

My cancer has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Expansion

Participants receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET) in Part 1; and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-64264681

Trial Overview The trial is testing JNJ-64264681's safety and optimal dose in two parts: first finding the best dose, then checking its safety at that dose in patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

How Is the Trial Designed?

Group I: JNJ-64264681: Dose Escalation and Expansion Experimental Treatment 1 Intervention

Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).

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

In a study of 10 patients with juvenile dermatomyositis (JDM) treated with Janus kinase inhibitors (JAKis) for at least 6 months, 5 patients achieved clinically inactive disease, indicating that JAKis can be effective for refractory cases.

While JAKis showed promise in improving muscle vasculopathy and reducing steroid use, there was a notable risk of herpes zoster infections in some patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JAK inhibitors are effective in a subset of patients with juvenile dermatomyositis: a monocentric retrospective study. Le Voyer, T., Gitiaux, C., Authier, FJ., et al.[2021]

In a phase III study involving 507 patients with rheumatoid arthritis, peficitinib (100 mg and 150 mg once daily) significantly improved symptoms compared to placebo, with ACR20 response rates of 57.7% and 74.5% respectively at week 12.

Peficitinib was well tolerated overall, although there was a higher incidence of serious infections and herpes zoster compared to placebo, indicating a need for monitoring but no clear dose-dependent increase in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). Tanaka, Y., Takeuchi, T., Tanaka, S., et al.[2020]

JAK inhibitors, particularly ruxolitinib, have become essential in treating classical BCR-ABL1-negative myeloproliferative neoplasms (MPN) like primary myelofibrosis (PMF) and polycythemia vera (PV), showing significant efficacy over the past several years.

Newer JAK inhibitors, such as pacritinib and Itacitinib, are being explored for their potential benefits, including reduced side effects and improved treatment outcomes, particularly in managing anemia associated with myelofibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BCR-ABL1-negative myeloproliferative neoplasms: a review of JAK inhibitors in the therapeutic armamentarium. Griesshammer, M., Sadjadian, P.[2021]

In a phase 2 study involving 104 patients with relapsed or refractory peripheral T-cell lymphoma, golidocitinib demonstrated an objective response rate of 44.3%, indicating significant anti-tumor activity, with 24% of patients achieving a complete response.

While 59% of patients experienced grade 3-4 drug-related adverse events, these were manageable and reversible, suggesting that golidocitinib has a favorable safety profile for further investigation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Song, Y., Malpica, L., Cai, Q., et al.[2023]

A study analyzing 126,815 safety reports found that the JAK inhibitors ruxolitinib, tofacitinib, and baricitinib are associated with increased risks of infectious adverse events, particularly viral, fungal, and mycobacterial infections.

Tofacitinib specifically showed a significant association with gastrointestinal perforation events, while no significant increase in major cardiovascular events was observed, indicating a need for careful monitoring of these risks in patients using JAK inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database. Hoisnard, L., Lebrun-Vignes, B., Maury, S., et al.[2023]

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. clinicaltrial.be clinicaltrial.be/en/details/59222?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Study of JNJ-64264681 in Participants With Non-Hodgkin... The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) in B cell non-Hodgkin lymphoma (NHL) and chronic ...

3. withpower.com withpower.com/trial/phase-1-lymphoma-non-hodgkin-6-2020-c975a

JNJ-64264681 for Non-Hodgkin's Lymphoma and Leukemia This trial is testing a new drug called JNJ-64264681 to find the best dose and ensure it is safe. It focuses on patients with specific blood cancers, ...

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

News - JNJ-4681 A study of JNJ-64264681 in participants with non-Hodgkin lymphoma and chronic lymphocytic leukemia (clinicaltrials.gov) P1, N=85, Completed.

5. 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 ...

6. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/64264681lym1001/

64264681LYM1001 JNJ-64264681 has been tested for safety in healthy volunteers for up to 10 days in 1 clinical trial and for up to 1 month in animals. Approximately 108 ...

7. mountsinai.org mountsinai.org/clinical-trials/study-of-jnj-64264681-in-participants-with-non-hodgkin-lymphoma-chronic-lymphocytic-leukemia

A Study of JNJ-64264681 in Participants With Non- ... Summary: The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic ...

8. medchemexpress.com medchemexpress.com/jnj-64264681.html?srsltid=AfmBOoqJgJpiq0oWYFXsdwqUu4LlfUdIz-a8BGjZ_6LZ0bfwePMrgQY1

JNJ-64264681 | BTK Inhibitor JNJ-64264681 is a potent, orally active, selective and irreversible covalent BTK inhibitor. JNJ-64264681 exhibits good pharmacokinetic characteristics and ...