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CAR T-cell Therapy
JNJ-75276617 for Acute Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) alterations
Must not have
Exclusion criteria related to stem cell transplant: a. Willing and able to undergo allogeneic stem cell transplant (if clinically indicated); b. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; c. Has evidence of graft versus host disease; d. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; e. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
Acute promyelocytic leukemia according to World Health Organization (WHO) 2016 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years and 9 months
Awards & highlights
Summary
This trial is testing a new drug to find the best dose and to see if it is safe and tolerated.
Who is the study for?
This trial is for adults with acute leukemia who have specific genetic alterations (KMT2A or NPM1), and whose disease has not improved after treatment, or they can't receive standard treatments. They must be in relatively good health otherwise, with acceptable blood counts and organ function. Women of childbearing age and men must agree to use contraception.Check my eligibility
What is being tested?
The study is testing JNJ-75276617 to find the safest dose that's also effective (Phase 2). It starts by increasing doses (Part 1) then tests this dose further for safety and effectiveness (Part 2).See study design
What are the potential side effects?
While the side effects of JNJ-75276617 are being studied, potential risks may include reactions at the infusion site, changes in blood counts, liver issues, fatigue, nausea, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My acute leukemia has specific genetic changes.
Select...
My acute leukemia has returned or is not responding to treatment, and I have no other treatment options.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a specific type of leukemia.
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My heart's electrical cycle length is within safe limits and I don't have a family history of Long QT syndrome.
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I have an active brain or spinal cord disease.
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I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years and 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years and 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate (ORR)
Plasma Concentration of JNJ-75276617
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: JNJ-75276617Experimental Treatment1 Intervention
Participants in Part 1 (dose escalation) will receive JNJ-75276617 orally on a 28-day cycle. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) has been identified. Participants in Part 2 (dose expansion) will receive JNJ-75276617 orally at one of the RP2D(s) determined in Part 1. Food effect cohort (optional) participants will receive JNJ-75276617 orally on Cycle 2 Day 1 under fasted condition and on Cycle 2 Day 2 under fed condition.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Leukemia include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using cytotoxic agents to kill rapidly dividing leukemia cells, but it also affects normal cells, leading to significant side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically inhibit abnormal proteins or pathways that drive leukemia cell growth, offering a more precise treatment with potentially fewer side effects. Immunotherapy leverages the patient's immune system to recognize and destroy leukemia cells, providing a novel approach that can be effective even in resistant cases.
Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the specific characteristics of their leukemia, potentially improving outcomes and minimizing adverse effects.
Immunotherapy in AML: a brief review on emerging strategies.Epigenetic deregulation in myeloid malignancies.Development of Personalized Molecular Therapy for Acute Myeloid Leukemia.
Immunotherapy in AML: a brief review on emerging strategies.Epigenetic deregulation in myeloid malignancies.Development of Personalized Molecular Therapy for Acute Myeloid Leukemia.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,143 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,797 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific type of leukemia.I agree to use a condom and not donate sperm during and 90 days after the study.I can take care of myself and am up and about more than half of my waking hours.My heart's electrical cycle length is within safe limits and I don't have a family history of Long QT syndrome.I haven't had cancer treatments like chemo or radiation in the last 4 weeks.I have an active brain or spinal cord disease.My acute leukemia has specific genetic changes.I have had a solid organ transplant.My acute leukemia has returned or is not responding to treatment, and I have no other treatment options.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-75276617
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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