RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies
Hematologic Malignancies
About this trial
This is an interventional treatment trial for Hematologic Malignancies
Eligibility Criteria
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. The estimated survival time is more than 3 months. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: Subjects with concomitant genetic syndromes associated with bone marrow failure states. Isolated extramedullary lesions Subjects with some cardiac conditions will be excluded. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade CNS3. 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. Presence of uncontrolled infections. Sujects with some anticancer therapy before CAR-T infusion will be excluded. Active uncontrolled acute infections. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. Subjects who are receiving systemic steroid therapy prior to screening. Subjects with acute graft-versus-host disease (GvHD) Having received live/attenuated vaccine within 4 weeks prior to screening. History of allergy to any component of the cell therapy product. Pregnant or breastfeeding women Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
Sites / Locations
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Experimental
RD13-02 cell infusion
drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10^8 CAR+ T cells; frequency : Once.