Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia
ConditionLeukemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14+
SponsorAnhui Provincial Hospital
About this trial
CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0/M1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk genetic abnormalities (such as TP53 mutations or complex karyotypes). CD7-positive AML patients typically have poor prognosis, poor response to standard chemotherapy, and shorter overall survival (OS). Targeted CD7 cell therapies may represent a promising direction for the treatment of these diseases.
Eligibility criteria
Qualifiers
Age ≥ 14 years, no gender restrictions;
Diagnosed with TALL/LBL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2023.V2); or diagnosed with AML according to the NCCN Acute Myeloid Leukemia Clinical Practice Guidelines (2023.V6);
Relapsed: after achieving complete remission(CR), peripheral blood or bone marrow shows >5% blast cells or extramedullary lesions in any site;
Refractory: primary refractory cases that did not achieve CR after standard induction chemotherapy.
Disqualifiers
Patients with a history of severe central nervous system disorders, such as uncontrolled epileptic seizures, stroke, severe brain injury with aphasia, paralysis, dementia, Parkinson's disease, or mental disorders;
Heart failure classified as NYHA functional class III or IV;
Any of the following unstable cardiovascular conditions occurring within the past 6 months prior to screening (including but not limited to): unstable angina, cerebral ischemia or cerebrovascular accident, myocardial infarction, severe arrhythmias requiring medication (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes); Undergone coronary angioplasty, coronary artery stent implantation, or coronary artery bypass surgery; experienced thrombosis or embolism events (e.g., cerebrovascular events [including transient ischemic attacks, but excluding lacunar cerebral infarction], deep vein thrombosis [excluding deep vein thrombosis caused by PICC catheter placement], pulmonary embolism, etc.);
Presence of disseminated intravascular coagulation;
Trial design
Treatments tested in this trial
- CD7 CAR-γδT cell（QH106）
- Fludarabine (FLU)
- Cyclophosphamide (CTX)
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov