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)

Korábbi kezelés

• Subjects with concomitant genetic syndromes associated with bone marrow failure states.
• Subjects with some anticancer therapy before CAR-T infusion will be excluded.
• Subjects who are receiving systemic steroid therapy prior to screening.
• Having received live/attenuated vaccine within 4 weeks prior to screening.

Más betegség

• 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.
• History of malignancy other than non-melanoma skin cancer or carcinoma.
• Presence of uncontrolled infections.
• Active uncontrolled acute infections.
• Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
• Subjects with acute graft-versus-host disease (GvHD)
• History of allergy to any component of the cell therapy product.

Egyéb

• 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).
• Primary immune deficiency.
• Pregnant or breastfeeding women
• Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

• 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.
• 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.