Status:
ENROLLING_BY_INVITATION
Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)
Lead Sponsor:
BGI, China
Collaborating Sponsors:
Shenzhen University General Hospital
Conditions:
AML
t(8;21)
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
This is a single arm、open 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 s...
Eligibility Criteria
Inclusion
- Age 18-75 years old (including 18, 75 years old), gender is not limited;
- According to WHO (2020) criteria, the subjects are diagnosed for recurrent or refractory t(8:21) acute myeloid leukemia or demonstrated persistant AML1-ETO positiving or genetic MRD recurrence after ≥3 cycles of intensive chemotherapy, as confirmed by quantitative PCR;
- The subjects voluntarily participate in the study and sign the Informed Consent Form by themselves or their legal guardians;
- The HLA types of subjects are HLA-A\* 11:01 or HLA-A\*02:01;
- Possessing the AML1-ETO(RUNX1-RUNX1T1) funsion gene;
- Disease progression after adequate first-line systemic treatment for remission, or disease progression after first-line or above systemic systemic treatment for ≥2 cycles , or without remission (CR or PR) after≥4 cycles of treatment ;
- No contraindications for collection of mononuclear cells from peripheral blood ;
- ECOG score ≤1;
- The survival time is exspected to be≥ 3 months;
- Have the ability to understand and be willing to sign the informed consent for this test.
Exclusion
- Tumor cells do not express AML1-ETO neoantigen;
- Active infection;
- Abnormal liver function \[TBil（total bilirubin)\>1.5×ULN, ALT\>2.5×ULN\], abnormal kidney function \[Scr（serum creatinine)\>1.5×ULN\];
- Unstable angina or 3/4 class of congestive heart failure according to New York Heart Association, or multiple organ dysfunction;
- HIV/AIDS patients;
- Participants who need treatment of long-term anticoagulation (warfarin or heparin) or antiplatelet(aspirin\>300mg/d; Clopidogrel\>75mg/d) ;
- Participants who received radiotherapy within 4 weeks ,prior to study initiation (blood collection);
- Known or suspected drug abuse or alcohol dependence;
- Patients with mental disorders or other medical conditions are unable to obtain informed consent and cooperate to complete the requirements of experimental treatment and examination procedures;
- Participants in other clinical trials within 30 days;
- Pregnant or lactating women and male subjects (or their partners) or female subjects who plan to become pregnant during the study period and within 6 months after the end of the study ,and do not wish to use a medically approved effective contraceptive method (such as an IUD or condom) during the study period;
- The investigator evaluates that the subject is unable or unwilling to comply with the requirements of the study protocol;
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06499025
Start Date
February 1 2024
End Date
December 30 2027
Last Update
August 28 2025
Active Locations (1)
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1
Shenzhen University General Hospital
Shenzhen, Guangdong, China