Phase
Condition
Hematologic Neoplasms
Neoplasms
Red Blood Cell Disorders
Treatment
RD13-02 cell infusion
Clinical Study ID
Ages 3-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 alanineaminotransferase(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 theinformed consent.
Exclusion
Exclusion Criteria:
For AML patients, there are acute promyelocytic leukemia (APL) and Abelson MurineLeukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemiawith acute(CML)-BC).
Subjects with concomitant genetic syndromes associated with bone marrow failurestates.
Subjects with some cardiac conditions will be excluded.
History of traumatic brain injury, consciousness disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which mightcompromise the ability of the subject to compliance with the obligations under theprotocol.
History of malignancy other than non-melanoma skin cancer or carcinoma.
Primary immune deficiency.
Presence of uncontrolled infections.
Subjects 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 latenthepatitis 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 subjectsineligible for the study.
Study Design
Connect with a study center
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu 221000
ChinaSite Not Available
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