🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06499025
Enrolling by invitation EARLY_Phase 1

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

NCT06499025 · tracked via the Priya Life Science China tracker
Sponsor
BGI, China
Phase
EARLY_Phase 1
Started
2024-02-01
Last updated
2025-08-28

Condition(s) studied

AMLt(8;21)Neoantigen

Investigational drug(s) / intervention(s)

targeted AML1-ETO neoantigen cytotoxic T cells (CTL)Cyclophosphamide injectionDecitabine InjectionLiposome mitoxantrone

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.

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

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-75 years old (including 18, 75 years old), gender is not limited; 2. 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; 3. The subjects voluntarily participate in the study and sign the Informed Consent Form by themselves or their legal guardians; 4. The HLA types of subjects are HLA-A\* 11:01 or HLA-A\*02:01; 5. Possessing the AML1-ETO(RUNX1-RUNX1T1) funsion gene; 6. 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 ; 7. No contraindications for collection of mononuclear cells from peripheral blood ; 8. ECOG score ≤1; 9. The survival time is exspected to be≥ 3 months; 10. Have the ability to understand and be willing to sign the informed consent for this test. Exclusion Criteria: 1. Tumor cells do not express AML1-ETO neoantigen; 2. Active infection; 3. Abnormal liver function \[TBil(total bilirubin)\>1.5×ULN, ALT\>2.5×ULN\], abnormal kidney function \[Scr(serum creatinine)\>1.5×ULN\]; 4. Unstable angina or 3/4 class of congestive heart failure according to New York Heart Association, or multiple organ dysfunction; 5. HIV/AIDS patients; 6. Participants who need treatment of long-term anticoagulation (warfarin or heparin) or antiplatelet(aspirin\>300mg/d; Clopidogrel\>75mg/d) ; 7. Participants who received radiotherapy within 4 weeks ,prior to study initiation (blood collection); 8. Known or suspected drug abuse or alcohol dependence; 9. 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; 10. Participants in other clinical trials within 30 days; 11. 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; 12. The investigator evaluates that the subject is unable or unwilling to comply with the requirements of the study protocol;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen University General Hospital Shenzhen Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06499025 on ClinicalTrials.gov ↗ ← All trials in China