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Recruiting EARLY_Phase 1 NCT04662294

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Trial Parameters

Condition Acute Myeloid Leukemia
Sponsor Zhejiang University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 108
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2021-11-18
Completion 2024-01-15
Interventions
CD70 CAR T-cells

Brief Summary

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

Eligibility Criteria

Inclusion Criteria: Inclusion criteria only for AML: 1. Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); 2. Relapsed or refractory CD70+ AML (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry); 4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; 5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 7. Estimated survival time ≥ 3 months; 8. ECOG performance status 0 to 2; 9. Patients or their lega

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