Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552416
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID
Brief 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 andor 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 andor 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 andor 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 106 cells Dose escalations will proceed using the modified 33 design up to the highest single flat dose of 400 x 106 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 andor HMA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None