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Recruiting NCT05618041

The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

Trial Parameters

Condition Acute Lymphoblastic Leukemia
Sponsor Hebei Senlang Biotechnology Inc., Ltd.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 14 Years
Max Age 75 Years
Start Date 2022-09-07
Completion 2027-09-06
Interventions
CAR-T Autologous T cell injection

Brief Summary

To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

Eligibility Criteria

Inclusion Criteria: * Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; * Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma; * Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation); * Age 14-75 (including threshold), gender unlimited; * Eastern Cooperative Oncology Group (ECOG) score ≤2; * HGB ≥ 70g/L (blood transfusion allowed); * Liver and kidney functions, heart and lung functions meet the following requirements: 1. Creatinine ≤ 1.5 × ULN; 2. Left ventricular ejection fraction ≥ 50%; 3. Blood oxygen saturation\>90%; 4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; * For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 an

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