Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499025
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-07
Brief Title:
Treatment of Relapsed or Refractory t8 21 AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells CTL
Sponsor:
BGI China
Organization:
BGI China
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety and Initial Efficacy of Targeted AML1-ETO Neoantigen Cytotoxic T Cells CTL in the Treatment of Relapsed or Refractory t8 21 AML
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To evaluate the safety and tolerability of targeted AML1-ETO neoantigen cytotoxic T cells CTL in the treatment of relapsed or refractory acute myeloid leukemia
2 To evaluate the effectiveness of targeted AML1-ETO neoantigen cytotoxic T cells CTLby the complete response rateCRR and overall survival OS followed
2 To evaluate the effectiveness of targeted AML1-ETO neoantigen cytotoxic T cells CTLby the complete response rateCRR and overall survival OS followed
Detailed Description:
This is a single armopen label and non-randomied clinical trial divided into dose exploration phase Part A and dose extension phase Part B
Part A Plan to enroll six subjects to evaluate the safety and tolerabilty of targeted neoantigen cytotoxic T cells CTLdetermine dose-limiting toxicityDLTexplore the maximum tolerated dose MTD or the recommended dose for later clilnical studiesThe DLT observation period is 28 days after the infusion of targeted neoantigen cytotoxic T cells CTL iniection One dose grouptotal number of cells is 5107bag and the another one total number of cells is 10107 bag is setted by the 33 test design
Part B Ten subjects are planned to be enrolled in the dose-exploration phase with the recommended dose to further evaluate the safetytolerability and its efficacy of targeted neoantigen cytotoxic T cells CTL in relapsed or refractory acute myeloid leukemia
Part A Plan to enroll six subjects to evaluate the safety and tolerabilty of targeted neoantigen cytotoxic T cells CTLdetermine dose-limiting toxicityDLTexplore the maximum tolerated dose MTD or the recommended dose for later clilnical studiesThe DLT observation period is 28 days after the infusion of targeted neoantigen cytotoxic T cells CTL iniection One dose grouptotal number of cells is 5107bag and the another one total number of cells is 10107 bag is setted by the 33 test design
Part B Ten subjects are planned to be enrolled in the dose-exploration phase with the recommended dose to further evaluate the safetytolerability and its efficacy of targeted neoantigen cytotoxic T cells CTL in relapsed or refractory acute myeloid leukemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KYLLHS-20230402A | OTHER | None | None |