RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL (NCT05902845) | Clinical Trial Compass
CompletedEarly Phase 1
RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL
China4 participantsStarted 2023-04-30
Plain-language summary
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
Who can participate
Age range3 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 3-70
✓. Diagnosis of r/r T-ALL/LBL.
✓. CD7 positive expression
✓. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
✓. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
✓. Left ventricular ejection fraction ≥ 50% .
✓. Baseline oxygen saturation ≥ 92% on room air.
✓. ECOG performance status of 0 to 2.
Exclusion criteria
✕. Sujects with concomitant genetic syndromes associated with bone marrow failure states.
✕. Sujects with some cardiac conditions will be excluded.
✕. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
✕. History of malignancy other than non-melanoma skin cancer or carcinoma.
✕. Primary immune deficiency.
What they're measuring
1
Overall response rate, ORR
Timeframe: Evaluate at 4 weeks after CAR-T infusion
2
Overall response rate, ORR
Timeframe: Evaluate at 8 weeks after CAR-T infusion
3
Overall response rate, ORR
Timeframe: Evaluate at 12 weeks after CAR-T infusion