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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

ARTEMIS Trial 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.Check my eligibility

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.See study design

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.

ARTEMIS Trial 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.

ARTEMIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 2 Active Disease Group

Phase 2 Adjuvant Group

Safety Lead-In

ARTEMIS 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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marker Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

288 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

Frequently Asked Questions

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

Has the FDA sanctioned MT-401 for medical use?

"Since this is a phase 2 trial, MT-401 has only been shown to be safe but not effective. We rate it a 2."

Answered by AI

Are investigators looking for more people to enroll in this trial at this time?

"The latest information on clinicaltrials.gov suggests that this study is still looking for eligible participants. The trial was originally posted on October 14th 2020 and was most recently updated on August 22nd 2022."

Answered by AI

How many people can join this test group at the most?

"The trial sponsor, Marker Therapeutics, Inc., needs to enroll 172 patients that meet the study's inclusion criteria from different locations, including University of Chicago in Chicago, Illinois and Montefiore Medical Center in Bronx, New york."

Answered by AI

Where are patients being seen for this research?

"The participating locations for this study are University of Chicago, Montefiore Medical Center, Baylor College of Medicine, and 17 other hospitals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

2020. "Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04511130.