QH101 Cell Therapy Relapsed/Refractory(R/R) Acute Myeloid Leukemia(AML) and Myelodysplastic Syndromes(MDS)

Inclusion Criteria

• •Selection criteria:
• •1. Age ≥ 14 years, no gender restrictions;
• •2. Diagnosed with AML according to the standards of the NCCN (2024 V2), ELN (2023), and the Chinese "Guidelines for the Diagnosis and Treatment of AML (2024 Edition)"; or diagnosed with MDS according to the standards of the NCCN (2024 V2), ELN (2023), and the Chinese "Expert Consensus on the Diagnosis and Treatment of MDS (2024 Edition)"; （1） Meets the criteria for R/R AML, including any of the following:
• •1. Relapsed: Leukemic cells reappear in the peripheral blood after complete remission, or Leukemic blasts≥5% in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or leukemic cell infiltration in extramedullary sites;
• •2. Refractory: Primary cases that fail to respond to two cycles of standard treatment, or cases that relapse within 12 months after consolidation intensive therapy following complete remission (CR), or cases that relapse after 12 months and fail to respond to conventional chemotherapy, or cases with two or more relapses, or cases with persistent extramedullary leukemia; （2）Meets the criteria for R/R MDS, including any of the following conditions:
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• •1. Relapsed: Patients who have achieved hematologic improvement or CR but subsequently experience hematologic decline (e.g., hemoglobin \<10 g/dL, platelets \<50×10⁹/L, neutrophils \<1.0×10⁹/L), or an increase in the proportion of blast cells in the bone marrow (≥5%), or the emergence of new cytogenetic abnormalities or molecular progression (e.g., increased TP53 mutation burden);
• •2. Refractory: No hematologic or bone marrow improvement after ≥4-6 cycles of hypomethylating agent (HMA) therapy (e.g., azacitidine or decitabine), or low-risk MDS resistant to erythropoietin or immunomodulatory agents (e.g., lenalidomide).
• •3. Expected survival time exceeds 3 months;
• •4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-2;
• •5. Organ function meets the following requirements: 1)Liver function must meet: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total bilirubin ≤ 3.0 × ULN. 2)Renal function must meet the following criteria: Serum creatinine ≤ 1.5 × upper limit of normal (ULN); 3)Cardiac function: Echocardiogram showing left ventricular ejection fraction ≥ 50%; 4)Pulmonary function: Normal oxygen saturation without oxygen supplementation.
• •6. Female participants of childbearing potential and male participants whose partners are of childbearing potential must use medically approved contraceptive measures or abstain from sexual intercourse during the study treatment period and for at least 6 months after the study treatment period. Female participants of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
• •7. No significant genetic disorders;
• •8. The subject or their legal guardian voluntarily participates in this study, understands the trial information, objectives, and risks described in the informed consent form, and can provide a signed and dated informed consent form;
• •9. The subject or their legal guardian is willing and able to comply with all trial requirements.