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

Launched by BGI, CHINA · Jul 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for adults with a specific type of leukemia called acute myeloid leukemia (AML) that has come back or hasn’t responded to previous treatments. The treatment involves using specially designed immune cells, known as cytotoxic T cells, that target a unique marker found in some leukemia cells. The main goals of the study are to see how safe this treatment is and whether it can help patients achieve a complete response, meaning no signs of the disease, and improve their overall survival.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with relapsed or refractory AML with a specific genetic change (t(8;21)). They should not have any other major health issues, active infections, or be pregnant. Participants can expect to receive close monitoring throughout the trial to ensure their safety and track how well the treatment works. This study is currently recruiting patients, and those interested should talk to their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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;
• • 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. Verified to have AE expression in tumor samples by histopathological examination ;
• • 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;