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

NCT06499025 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-28

No results posted yet for this study

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 (CTL)，by the complete response rate(CRR) and overall survival (OS) followed.

Conditions

  • AML
  • t(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

Sponsors & Collaborators

  • Shenzhen University General Hospital

    collaborator OTHER

  • BGI, China

    lead OTHER

Principal Investigators

  • LiXin Wang, Doctor · Shenzhen University General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499025 on ClinicalTrials.gov