Acute Myeloid LeukemiaPhase 2ARTEMISNCT04511130
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
A Phase 2 study testing MT-401 in people with Acute Myeloid Leukemia and Stem Cell Transplantation, run by Marker Therapeutics, Inc. at 18 sites in United States.
Trial summary
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Stem Cell Transplantation
- What is being tested?
- MT-401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 18 sitesUnited States
- Study dates
- 14 Oct 2020to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
- Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or
- Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
- First relapse (MRD+ or frank relapse) post-HSCT
- Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
- Safety Lead-in defined as patients who fit all the criteria for Group 2 only
Show all 15Show fewer
- Are ≥18 years of age
- Karnofsky/ Lansky score of ≥60
- Life expectancy ≥12 weeks
- Adequate blood, liver, and renal function
- Blood: Hemoglobin ≥7.0 g/dL (can be transfused)
- Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal
- Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min
- 7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.
- 8. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit
Who cannot join
- Clinically significant or severely symptomatic intercurrent infection
- Pregnant or lactating
- For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
- For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
- Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 303222
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Chicago
Chicago, Illinois, 77027
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
City of Hope National Medical Center
Duarte, California, 91010
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Mayo Clinical Cancer Center-Florida
Jacksonville, Florida, 32224
Moores Cancer Center at University of Californa San Diego
La Jolla, California, 92093
UCLA Department of Medicine
Los Angeles, California, 90095
Yale Cancer Center
New Haven, Connecticut, 06519
Weill Cornell Medicine | NewYork-Presbyterian
New York, New York, 10027
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic Cancer Center-Rochester
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).
Read the detailed description
This study is in patients aged ≥18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML.
Potential patients for the study may be screened/enrolled:
- Prior to their first allogeneic HSCT. or
- Patients experiencing their first relapse post-allogeneic transplant.
Patients eligible for the study will be placed into one of two groups:
- Adjuvant (Group 1): Patients screened prior to their HSCT with CR without minimal residual disease (CRMRD-) at 85-130 days post transplant will be randomized (1:1) in an unblinded fashion to:
- MT-401 (Arm A)
- SOC (Arm B)
- Active Disease: (Group 2): Patients meeting the following criteria will be assigned to Group 2 and will receive MT 401:
- Patients who experience relapse (patients with MRD [MRD+] or frank relapse) at or prior to post-transplant Day 85-130
- Patients in Arm B of Group 1 (SOC) who develop relapse (MRD+ or frank relapse) post-HSCT (crossover patients)
- Patients who do not consent prior to HSCT but are experiencing their first relapse (MRD+ or frank relapse) and have the same donor available for manufacturing
- Conditions
- Acute Myeloid Leukemia, Stem Cell Transplantation
- Being tested
- MT-401
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-401Drug
Also called zedenoleucel
MT-401 (zedenoleucel) is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells obtained from apheresis.
| Study group | Role | What they receive |
|---|---|---|
| MT-401 following HSCT | Experimental | Treatment with MT-401 at 90 days following HSCT Receives: Drug: MT-401 |
| Standard of Care following HSCT | No intervention | Standard of Care |
| MT-401 following relapse | Experimental | Treatment with MT-401 following relapse after first HSCT Receives: Drug: MT-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Lead-In
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Measured: Baseline through Cycle 1 (28 Days)
Phase 2 Adjuvant Group
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
Measured: Up to 24 months after the first participant is randomized
Phase 2 Active Disease Group
Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
Measured: Up to 12 months
Phase 2 Active Disease Group
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start14 Oct 2020
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Despite a plan to enroll \~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marker Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nishan Rajakumaraswamy, MD, Study director, Marker Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511130
- Sponsor's protocol ID
- MRKR-19-401
- Other IDs
- FD-R-7272
- Acronym
- ARTEMIS
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2020
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04511130
- Acronym / sponsor ID
- ARTEMIS / MRKR-19-401
- Conditions
- Acute Myeloid Leukemia, Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite a plan to enroll \~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Marker Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).
Detailed description
This study is in patients aged ≥18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML.
Potential patients for the study may be screened/enrolled:
- Prior to their first allogeneic HSCT. or
- Patients experiencing their first relapse post-allogeneic transplant.
Patients eligible for the study will be placed into one of two groups:
- Adjuvant (Group 1): Patients screened prior to their HSCT with CR without minimal residual disease (CRMRD-) at 85-130 days post transplant will be randomized (1:1) in an unblinded fashion to:
- MT-401 (Arm A)
- SOC (Arm B)
- Active Disease: (Group 2): Patients meeting the following criteria will be assigned to Group 2 and will receive MT 401:
- Patients who experience relapse (patients with MRD [MRD+] or frank relapse) at or prior to post-transplant Day 85-130
- Patients in Arm B of Group 1 (SOC) who develop relapse (MRD+ or frank relapse) post-HSCT (crossover patients)
- Patients who do not consent prior to HSCT but are experiencing their first relapse (MRD+ or frank relapse) and have the same donor available for manufacturing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-401 following HSCT | Experimental | Drug: MT-401Treatment with MT-401 at 90 days following HSCT |
| Standard of Care following HSCT | No intervention | –Standard of Care |
| MT-401 following relapse | Experimental | Drug: MT-401Treatment with MT-401 following relapse after first HSCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
- Are ≥18 years of age
- Karnofsky/ Lansky score of ≥60
- Life expectancy ≥12 weeks
- Adequate blood, liver, and renal function
Key exclusion criteria (5 listed)
- Clinically significant or severely symptomatic intercurrent infection
- Pregnant or lactating
- For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
- For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
- Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-401Also: zedenoleucelMT-401 (zedenoleucel) is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells obtained from apheresis. | Drug | MT-401 following HSCT, MT-401 following relapse |
Primary outcome
Safety Lead-In
Time frame: Baseline through Cycle 1 (28 Days)
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Phase 2 Adjuvant Group
Time frame: Up to 24 months after the first participant is randomized
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
Phase 2 Active Disease Group
Time frame: Up to 12 months
Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
Phase 2 Active Disease Group
Time frame: Up to 24 months
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
Results and safety
The study was stopped early (reason given: Despite a plan to enroll \~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nishan Rajakumaraswamy, MD study director
Marker Therapeutics
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-401 in people with Acute Myeloid Leukemia and Stem Cell Transplantation, run by Marker Therapeutics, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Despite a plan to enroll \~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Lead-In (time frame: Baseline through Cycle 1 (28 Days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.