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CAR T-cell Therapy

MT-401 for Acute Myeloid Leukemia Post-Stem Cell Transplant (ARTEMIS Trial)

Phase 2
Waitlist Available
Research Sponsored by Marker Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First relapse (MRD+ or frank relapse) post-HSCT
Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
Must not have
For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
Clinically significant or severely symptomatic intercurrent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment on patients who have had a bone marrow transplant and are still experiencing leukemia. The treatment is administered in a single dose and the trial will monitor its safety and efficacy.

Who is the study for?
This trial is for adults over 18 with Acute Myeloid Leukemia (AML) who've had their first stem cell transplant and are in remission without detectable disease. They must have good performance status, adequate organ function, and a life expectancy of at least 12 weeks. Those with severe graft-versus-host disease or significant infections can't participate.
What is being tested?
The study tests MT-401's safety and effectiveness in AML patients post-first allogeneic stem cell transplant. It's a Phase 2 trial where participants receive a set dose of MT-401 to see if it helps prevent leukemia from returning.
What are the potential side effects?
While specific side effects for MT-401 aren't listed, similar treatments may cause immune reactions, fatigue, blood count changes, liver or kidney issues. Side effects vary by individual based on their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned after my stem cell transplant.
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My AML has returned after my first bone marrow transplant.
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I am about to have my first stem cell transplant and my cancer is not detectable before the transplant.
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My liver tests are within the required range.
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My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving other cancer treatments alongside or after MT-401.
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I am currently suffering from a severe infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 2 Active Disease Group
Phase 2 Adjuvant Group
Safety Lead-In

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
Active Control
Group I: MT-401 following relapseExperimental Treatment1 Intervention
Treatment with MT-401 following relapse after first HSCT
Group II: MT-401 following HSCTExperimental Treatment1 Intervention
Treatment with MT-401 at 90 days following HSCT
Group III: Standard of Care following HSCTActive Control1 Intervention
Standard of Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-401
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Marker Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
400 Total Patients Enrolled
Mythili Koneru, MD, PhDStudy DirectorMarker Therapeutics

Media Library

MT-401 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04511130 — Phase 2
Acute Myeloid Leukemia Research Study Groups: MT-401 following relapse, MT-401 following HSCT, Standard of Care following HSCT
Acute Myeloid Leukemia Clinical Trial 2023: MT-401 Highlights & Side Effects. Trial Name: NCT04511130 — Phase 2
MT-401 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04511130 — Phase 2
~9 spots leftby Dec 2025
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