CAR T-cell Therapy

JNJ-75276617 for Acute Myeloid Leukemia

Q: 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.

Q: 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.

Q: 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.

Q: Has the FDA sanctioned JNJ-75276617 for public use?

Our team at Power believe that JNJ-75276617 carries a safety <a href="https://www.withpower.com/clinical-trials/ra">ra</a>ting of 1 due to the limited evidence available in Phase 1 trials, which typically provide only preliminary data on both efficacy and security.

Q: 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.

Hosp. de la Santa Creu i Sant Pau, Barcelona, Spain

JNJ-75276617 +4 morePhase 1RecruitingResearch Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 2 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (>=) 75 years of age or >=18 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

~3250

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

952 Previous Clinical Trials

6,375,468 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy Director

Janssen Research & Development, LLC

729 Previous Clinical Trials

3,957,100 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

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

2022. "A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453903.