RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies

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.

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.

Egyéb

• Isolated extramedullary lesions
• With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
• Primary immune deficiency.

• Age 3-70
• Diagnosis of r/r NK/T lymphoma.
• 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.