Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With … (NCT05907603) | Clinical Trial Compass
CompletedEarly Phase 1
Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)
China8 participantsStarted 2023-03-08
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/AML, 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/AML.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion criteria
✕. For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
✕. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
✕. Subjects 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.
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