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CAR T-cell Therapy

JNJ-75276617 Combination Therapy for Acute Myeloid 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
ECOG performance status grade of 0, 1 or 2
Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1 / KMT2A alterations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years 3 months
Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is safe to use with other treatments for AML. They will also expand to study the safety and tolerability of the new drug at the recommended Phase 2 dose.

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) as per WHO criteria, including those with de novo or secondary AML and relapsed/refractory cases. Participants must be in relatively good health (ECOG grade 0-2), have adequate organ function, not require supplemental oxygen, and women of childbearing potential must test negative for pregnancy.Check my eligibility
What is being tested?
The study tests JNJ-75276617 combined with other AML therapies like Venetoclax, Azacitidine, Cytarabine, Daunorubicin or Idarubicin to find the safest and most effective dose. It aims to establish a recommended Phase 2 dose and assess safety at that level.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood cell counts; liver or kidney issues; bleeding problems; heart complications; allergic reactions to the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My AML diagnosis fits WHO criteria, including specific genetic changes.
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My blood, liver, and kidney tests are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 3 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 Adverse Events (AEs)
Number of Participants with Adverse Events (AEs) by Severity
Number 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
Number of Participants with Depletion of Leukemic Blasts
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: Newly Diagnosed Chemotherapy Eligible SettingExperimental Treatment3 Interventions
Participants will receive combination of JNJ-75276617 with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >=18 to <75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.
Group II: Arm B: Newly Diagnosed Chemotherapy Ineligible SettingExperimental Treatment3 Interventions
Participants will receive JNJ-75276617 in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (>=)18 years of age to less than (<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Group III: Arm A: Relapsed/Refractory SettingExperimental Treatment3 Interventions
Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with either venetoclax (VEN) (Cohort A1: JNJ75276617+VEN) or azacitidine (AZA) (Cohort A2: JNJ-75276617+AZA) or VEN+AZA (Cohort A3: JNJ-75276617+VEN+AZA) to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive JNJ-75276617 in combination with AML directed therapies at the RP2D(s).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine (AZA)
2012
Completed Phase 1
~10
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,384,138 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,757 Total Patients Enrolled

Media Library

JNJ-75276617 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05453903 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Arm A: Relapsed/Refractory Setting, Arm B: Newly Diagnosed Chemotherapy Ineligible Setting, Arm C: Newly Diagnosed Chemotherapy Eligible Setting
Acute Myeloid Leukemia Clinical Trial 2023: JNJ-75276617 Highlights & Side Effects. Trial Name: NCT05453903 — Phase 1
JNJ-75276617 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453903 — Phase 1

Frequently Asked Questions

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

Are there any US-based locations that are hosting this experiment?

"Currently, 7 medical centres are recruiting participants for this study. These can be found in Duarte, Birmingham and Los Angeles as well as four other locations across the US. It is wise to pick a trial site close by so that travelling becomes minimal if you decide to participate."

Answered by AI

Are there still available slots in this trial for participants?

"According to the info posted on clinicaltrials.gov, this investigation is currently recruiting patients. The trial was initially listed on October 4th 2022 and its details were most recently amended on December 1st of the same year."

Answered by AI

How many participants are currently enrolled in this research?

"Affirmative. According to information on clinicaltrials.gov, this trial is still enrolling participants and was initially posted at the beginning of October 2022 with its last update happening in December of that year. The medical research calls for 150 patients from 7 different sites."

Answered by AI

Has the FDA sanctioned JNJ-75276617 for public use?

"Our team at Power believe that JNJ-75276617 carries a safety rating of 1 due to the limited evidence available in Phase 1 trials, which typically provide only preliminary data on both efficacy and security."

Answered by AI

What objectives is this clinical trial hoping to accomplish?

"The primary objective of the two-year clinical trial is to evaluate participant's experiences with adverse events. Secondary objectives include recording patient responses in terms of complete remission with partial hematologic recovery (CRh) meeting certain criteria, calculating how many participants experience depletion of leukemic blasts, and observing any changes in expression levels among menin-KMT2A target genes."

Answered by AI
~8 spots leftby May 2024