Clinical trial · Interventional
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MT-401 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MT-401 following HSCT
- description
- Treatment with MT-401 at 90 days following HSCT
- interventionNames
- Drug: MT-401
- type
- NO_INTERVENTION
- label
- Standard of Care following HSCT
- description
- Standard of Care
- type
- EXPERIMENTAL
- label
- MT-401 following relapse
- description
- Treatment with MT-401 following relapse after first HSCT
- interventionNames
- Drug: MT-401
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria
1. 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
2. Are ≥18 years of age
3. Karnofsky/ Lansky score of ≥60
4. Life expectancy ≥12 weeks
5. 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
Exclusion Criteria
1. Clinically significant or severely symptomatic intercurrent infection
2. Pregnant or lactating
3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
5. 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-401References
Publications (0)
Data not yet available