Acute Myeloid Leukemia, in RelapsePhase 1RAPIDNCT06552416
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
A Phase 1 study testing MT-401-OTS in people with Acute Myeloid Leukemia, in Relapse and MDS, run by Marker Therapeutics, Inc. at 3 sites in United States.
Trial summary
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or </= 10% blast following prior induction therapy or at least 4 cycles… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse, MDS
- What is being tested?
- MT-401-OTS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2025to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- General
- Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF
- Must have a life expectancy ≥ 12 weeks
- Must have an ECOG performance status of 0-2
- Must have available MT-401-OTS product with a ≥ 2/8 HLA match Disease Characteristics
- For participants with AML:
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- Must have a confirmed diagnosis of AML or MDS/AML per 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 International Consensus Criteria
- Must have intermediate or high-risk disease based on ELN 2022 criteria.
- If no targetable mutation is present, must have received 1 prior standard regimen with at least 4 cycles of standard therapy containing an HMA or a standard cytarabine-containing induction therapy
- If targetable mutation is present, must have received a regimen that includes commercially available targeted therapy unless unable to tolerate or the participant declines (must be documented in the informed consent). If targeted therapy was not administered as part of first-line of therapy, a second regimen is allowed.
- Must have either: ≤ 10% bone marrow blasts and ≤ 5% peripheral blasts during screening and not be considered to have hyperproliferating disease at diagnosis or after treatment OR Evidence of MRD based on evaluation at a local laboratory
- For participants with MDS:
- Must have confirmed diagnosis of MDS based on 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 ICC criteria
- Must have high-risk or very-high-risk disease based on IPSS-M (ie, not evolved to AML)
- Must have received standard treatment with at least 4 cycles of an HMA and have evidence of continued disease, including morphologic disease or MRD-positive
- Must have bone marrow blasts ≤ 10% at screening Health Status
- Must have adequate coagulation, hepatic, renal, and cardiac function:
- PT/INR and PTT/aPTT < 1.3 × ULN
- AST and ALT < 3 × ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT < 5 × ULN is permitted.
- Total bilirubin ≤ 1.5 × ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin (2 × ULN is permitted)
- eGFR ≥ 40 mL/min by the MDRD formula
- LVEF ≥ 45% (prior to apheresis and lymphodepletion) Sex
- Women of childbearing potential are eligible to participate if they agree to the following during the intervention period and for at least 1 year after the last infusion of MT-401-OTS:
- Must use a contraceptive method that is highly effective (ie, with a failure rate of < 1% per year; see Section 10.3), preferably with low user dependency PLUS
- Must agree not to donate eggs (ie, ova and oocytes) for the purpose of reproduction
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-401-OTS:
- Must refrain from donating sperm
- PLUS either:
- Must be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception (see Section 10.3) as a condom may break or leak
Who cannot join
- Disease-Related
- Have leukemic involvement in the CNS
- Have other extramedullary disease involvement (except hepatosplenic involvement)
- Have APL Medical Conditions
- Have primary immunodeficiency
- Have severe or uncontrolled autoimmune disorder
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- Have a history or presence of clinically relevant CNS pathology, such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
- Have active malignancies (ie, those that are progressing or have required treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this inclusion include the following:
- Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured
- Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ
- Adequately treated cervical carcinoma in situ without evidence of disease
- History of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen-deprivation therapy
- A malignancy that is considered cured with minimal risk of recurrence
- Have any active systemic infection requiring therapy (viral, bacterial, or fungal), including HIV
- Have active hepatitis B or C infection or other clinically active liver diseases, as defined below:
- Seropositivity for hepatitis B as defined by a positive test for HbsAg Participants with resolved infection (ie, participants who are HbsAg-negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Those who are RT PCR-positive will be excluded.
- Participants with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT PCR.
- Active hepatitis C infection as defined by being positive for a nucleic acid test for HCV RNA
- Have Class III or IV congestive heart failure per New York Association
- Have unstable angina
- Have a history or evidence of current, uncontrolled, clinically significant, unstable arrhythmias
- Have an oxygen saturation on room air of ≤ 92%
- Have clinically significant reversible nonhematologic toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline Note: Participants with clinically nonsignificant toxicities, such as asymptomatic laboratory values, will be allowed on study.
- Prior/Concomitant Therapies
- Received prior treatments for underlying malignancy, except as specified in the Inclusion Criteria. Participants with AML secondary to MDS may have received prior treatment for MDS.
- Have had prior HSCT
- Are receiving concurrent therapies other than HMA, as delineated in the study design
- Have received hematopoietic growth factors within 2 days of lymphodepleting conditioning regimen
- Have a history of severe allergic reactions/intolerance to any of the study intervention components, including the conditioning regimen, HMA, or DSMO, or to tocilizumab
- Have had major surgery within 14 days (central line placement allowed)
- Have received systemic steroids (exception: physiological doses of steroids allowed) or other immunosuppressive therapies within 14 days prior to lymphodepleting conditioning regimen Other
- Are unable to be matched with MT-401-OTS product inventory
- Are pregnant or breastfeeding
- Have any other issue that, in the opinion of the treating physician, would make the participant ineligible for the study or unable to comply with its requirements
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91006
Stephanie Kasten, 626-215-2835, skasten@coh.org
Shukaib Arslan, MD
- Recruiting
KU Cancer Center
Kansas City, Kansas, 66160
Rafaela Nelson, 913-945-9226, rbarbosafernandes@kumc.edu
Haitham Abdelhakim
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Sarah Starr, 813-745-2690, sarah.starr@moffitt.org
Nelli Bejanyan
About this study
Official title: A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or </= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with </= 10% blasts following treatment with an HMA-based therapy.
Read the detailed description
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or </= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with </= 10% blasts following treatment with an HMA-based therapy. Participants must meet all eligibility criteria. Once a suitable MT-401-OTS product is confirmed, the participant will receive a lymphodepleting conditioning regimen consisting of fludarabine and cyclophosphamide daily from Day -7 to Day -5. Bendamustine (administered on Days -6 and -5) may be used for participants with underlying toxicities or if lack of availability precludes the use of fludarabine and/or cyclophosphamide. Two standard doses of an HMA (azacitidine or decitabine) will be administered on Day -4 to -3. MT-401-OTS will be administered IV over 10 minutes on Day 0. Safety evaluations will be performed throughout the study. Disease assessments will be performed at regular intervals based on 2022 ELN criteria for AML and the 2023 response criteria for higher-risk MDS. The dose escalations will begin with Cohort 1 which a single MT-401-OTS dose administered at a flat dose of 100 X 10^6 cells). Dose escalations will proceed using the modified 3+3 design up to the highest single flat dose of 400 x 10^6 cells. If a clinical safety issue should arise in Cohort 1, a lower DL may be explored. Additionally, Cohort 4 is an optional cohort that may be considered based on the cumulative data from Cohorts 1 through 3 to asses alternative dosing schedules (split dosing) of 400 X 10^ 6 cells or without lymphodepletion and/or HMA.
- Conditions
- Acute Myeloid Leukemia, in Relapse, MDS
- Being tested
- MT-401-OTS
- 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-401-OTSDrug
MT-401-OTS is an off the shelf cellular therapy product given by IV infusion through either a peripheral or central line.
| Study group | Role | What they receive |
|---|---|---|
| Cohort -1 | Experimental | 50 × 106 cells flat dose, 1 dose infused on Day 0 Receives: Drug: MT-401-OTS |
| Cohort 1 | Experimental | 100 × 106 cells flat dose, 1 dose infused on Day 0 Receives: Drug: MT-401-OTS |
| Cohort 2 | Experimental | 200 × 106 cells flat dose, 1 dose infused on Day 0 Receives: Drug: MT-401-OTS |
| Cohort 3 | Experimental | 400 × 106 cells flat dose, 1 dose infused on Day 0 Receives: Drug: MT-401-OTS |
| Cohort 4 (optional) | Experimental | up to 400 × 106 cells flat dose TBD based on data from Cohorts 1-3; may include split dosing, dosing with or without lymphodepleting conditioning regimen, or dosing with or without HMA Receives: Drug: MT-401-OTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MT-401-OTS
Assess:
- Incidence of DLTs to determine the RP2D
- Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0
- Acute GVHD per 2016 MAGIC criteria
- CRS and ICANS per ASTCT criteria
Measured: Through study completion. Approximately 5 years
Tolerability of MT-401-OTS
cGVHD per 2014 NIH consensus criteria for cGVHD
Measured: Through study completion. Approximately 5 years
Secondary outcomes (2)
To assess the efficacy of MT-401-OTS in participants with high-risk or very-high-risk MDS per IPSS-M who have evidence of disease following at least 4 cycles of a HMA
Per 2023 IWG criteria for higher-risk MDS:
- CR rate
- DOCR
- ORR
- DOR
Measured: Following conclusion of the disease assessment of last MDS subject treated. Approximately 2 years
To assess the efficacy of MT-401-OTS in participants with intermediate or high-risk AML per 2022 ELN criteria who have evidence of disease following induction therapy or at least 4 cycles of nonintensive treatment
Per 2022 ELN Criteria for AML:
- Rate of MRD negativity
- CR, DOCR
- ORR, DOR
Measured: Following conclusion of the disease assessment of last AML subject treated. Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start16 Jun 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marker Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center, H. Lee Moffitt Cancer Center and Research Institute, City of Hope National Medical Center, FDA Office of Orphan Products Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552416
- Sponsor's protocol ID
- MRKR-21-401-OTS
- Other IDs
- 5R01FD007272-02
- Acronym
- RAPID
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be developed once it is determined that the results of this study may be published or presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)
- ClinicalTrials.gov ID
- NCT06552416
- Acronym / sponsor ID
- RAPID / MRKR-21-401-OTS
- Conditions
- Acute Myeloid Leukemia, in Relapse, MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marker Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center, H. Lee Moffitt Cancer Center and Research Institute, City of Hope National Medical Center, FDA Office of Orphan Products Development
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Aug 2024 (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 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or </= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with </= 10% blasts following treatment with an HMA-based therapy.
Detailed description
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or </= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with </= 10% blasts following treatment with an HMA-based therapy. Participants must meet all eligibility criteria. Once a suitable MT-401-OTS product is confirmed, the participant will receive a lymphodepleting conditioning regimen consisting of fludarabine and cyclophosphamide daily from Day -7 to Day -5. Bendamustine (administered on Days -6 and -5) may be used for participants with underlying toxicities or if lack of availability precludes the use of fludarabine and/or cyclophosphamide. Two standard doses of an HMA (azacitidine or decitabine) will be administered on Day -4 to -3. MT-401-OTS will be administered IV over 10 minutes on Day 0. Safety evaluations will be performed throughout the study. Disease assessments will be performed at regular intervals based on 2022 ELN criteria for AML and the 2023 response criteria for higher-risk MDS. The dose escalations will begin with Cohort 1 which a single MT-401-OTS dose administered at a flat dose of 100 X 10^6 cells). Dose escalations will proceed using the modified 3+3 design up to the highest single flat dose of 400 x 10^6 cells. If a clinical safety issue should arise in Cohort 1, a lower DL may be explored. Additionally, Cohort 4 is an optional cohort that may be considered based on the cumulative data from Cohorts 1 through 3 to asses alternative dosing schedules (split dosing) of 400 X 10^ 6 cells or without lymphodepletion and/or HMA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort -1 | Experimental | Drug: MT-401-OTS50 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 1 | Experimental | Drug: MT-401-OTS100 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 2 | Experimental | Drug: MT-401-OTS200 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 3 | Experimental | Drug: MT-401-OTS400 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 4 (optional) | Experimental | Drug: MT-401-OTSup to 400 × 106 cells flat dose TBD based on data from Cohorts 1-3; may include split dosing, dosing with or without lymphodepleting conditioning regimen, or dosing with or without HMA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (30 listed)
- General
Key exclusion criteria (34 listed)
- Disease-Related
- Participants with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT PCR.
- Prior/Concomitant Therapies
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-401-OTSMT-401-OTS is an off the shelf cellular therapy product given by IV infusion through either a peripheral or central line. | Drug | Cohort -1, Cohort 1, Cohort 2, Cohort 3, Cohort 4 (optional) |
Primary outcome
Safety of MT-401-OTS
Time frame: Through study completion. Approximately 5 years
Assess: * Incidence of DLTs to determine the RP2D * Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0 * Acute GVHD per 2016 MAGIC criteria * CRS and ICANS per ASTCT criteria
Tolerability of MT-401-OTS
Time frame: Through study completion. Approximately 5 years
cGVHD per 2014 NIH consensus criteria for cGVHD
2 secondary outcomes
To assess the efficacy of MT-401-OTS in participants with high-risk or very-high-risk MDS per IPSS-M who have evidence of disease following at least 4 cycles of a HMA
Time frame: Following conclusion of the disease assessment of last MDS subject treated. Approximately 2 years
To assess the efficacy of MT-401-OTS in participants with intermediate or high-risk AML per 2022 ELN criteria who have evidence of disease following induction therapy or at least 4 cycles of nonintensive treatment
Time frame: Following conclusion of the disease assessment of last AML subject treated. Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. IPD sharing plan will be developed once it is determined that the results of this study may be published or presented at scientific meetings.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-401-OTS in people with Acute Myeloid Leukemia, in Relapse and MDS, run by Marker Therapeutics, Inc. at 3 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 30 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Allison, BS (713-400-6400, pallison@markertherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of MT-401-OTS (time frame: Through study completion. Approximately 5 years). The study lists 2 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 16 Dec 2025.