← Back to Search

CAR T-cell Therapy

JNJ-75276617 for Acute Leukemia

Phase 1
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
Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count <= 30 * 10^9/liter (L) (hydroxyurea may be used to lower WBC count at screening and during study; (b) Chemistry: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 * upper limit of normal (ULN), total serum bilirubin <= 1.5 * ULN (participants with elevated bilirubinemia, such as Gilbert's syndrome, may enroll if conjugated bilirubin is within clinically acceptable range) and renal function; Estimated or measured glomerular filtration rate >= 60 milliliter per minute (mL/min)/1.73 meter square (m^2) per four variable modified diet in renal disease (MDRD) equation
Relapsed or refractory acute leukemia and has exhausted, or is ineligible for, available therapeutic options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years and 10 months
Awards & highlights
No Placebo-Only Group

Study 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 below
Select...
My acute leukemia has returned or is not responding to treatment, and I have no other treatment options.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I agree to use a condom and not donate sperm during and 90 days after the study.
Select...
My acute leukemia has specific genetic changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years and 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years and 10 months for reporting.

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
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
Duration of Response (DOR)
Number of Participants with Depletion of Leukemic Blasts
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,714 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,827 Total Patients Enrolled

Media Library

JNJ-75276617 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04811560 — Phase 1
Acute Leukemia Research Study Groups: JNJ-75276617
Acute Leukemia Clinical Trial 2023: JNJ-75276617 Highlights & Side Effects. Trial Name: NCT04811560 — Phase 1
JNJ-75276617 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811560 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this clinical experiment?

"The sponsor, Janssen Research & Development, LLC is responsible for recruiting a total of 110 participants that meet the clinical trial's eligibility requirements. NYU Langone Medical Center in New york City and Cityof Hope in Duarte, California are two of many locations where patients may have access to this medical study."

Answered by AI

What is the geographic scope of this clinical investigation?

"This clinical trial is enrolling participants at NYU Langone Medical Center in New york, City of Hope in Duarte, California and the University of California San Francisco located in San Francisco alongside many other sites."

Answered by AI

What outcomes is this medical investigation attempting to realize?

"The trial sponsor, Janssen Research & Development LLC, has reported that the primary outcome they will be measuring over a maximal 28 day cycle is Adverse Events (AEs) as an indicator of safety and tolerability. Secondary outcomes include Plasma Concentration of JNJ-75276617, Number of Participants with Depletion of Leukemic Blasts, and Duration of Response (DOR)."

Answered by AI

Is there capacity for additional participants in this research endeavor?

"Affirmative. Clinicaltrials.gov records reflect that this medical research, which was initially uploaded on May 19th 2021, is recruiting now. A total of 110 participants need to be enrolled from 8 distinct locations."

Answered by AI

Has JNJ-75276617 been accepted by the FDA yet?

"JNJ-75276617 has yet to be fully tested, so our team gave it a 1 on the safety scale. This is because Phase 1 trials are not intended to demonstrate efficacy or provide adequate data regarding its security."

Answered by AI
~29 spots leftby Feb 2025