Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)

EARLY_PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2027

Conditions
AMLt(8;21)Neoantigen
Interventions
BIOLOGICAL

targeted AML1-ETO neoantigen cytotoxic T cells (CTL)

After subject screening, peripheral blood mononuclear cell #PBMC# donors matching half or more of the subject's HLA matching will undergo blood collection to prepare neoantigen cytotoxic T cells. Neoantigen cytotoxic T cells preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning. Chemotherapy preconditioning will be performed before neoantigen cytotoxic T cells transfusion.

DRUG

Cyclophosphamide injection

Cyclophosphamide injection will be performed in -10 to -8d before neoantigen cytotoxic T cells transfusion

DRUG

Decitabine Injection

Decitabine Injection will be performed in -12 to -8d before neoantigen cytotoxic T cells transfusion

DRUG

Liposome mitoxantrone

Liposome mitoxantrone will be performed in -9 to -8d before neoantigen cytotoxic T cells transfusion

Trial Locations (1)

Unknown

Shenzhen University General Hospital, Shenzhen

All Listed Sponsors
collaborator

Shenzhen University General Hospital

OTHER

lead

BGI, China

OTHER