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Clinical Trials in China / NCT05618041
Recruiting Not applicable

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

NCT05618041 · tracked via the Priya Life Science China tracker
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Phase
Not applicable
Started
2022-09-07
Last updated
2025-06-24

Condition(s) studied

Acute Lymphoblastic LeukemiaLymphomaMultiple Myeloma

Investigational drug(s) / intervention(s)

CAR-T Autologous T cell injection

CAR-T Autologous T cell injection: Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine;Procedure: Leukapheresis

Study summary

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

Eligibility

Sex
ALL
Min age
14 Years
Max age
75 Years
Healthy volunteers
No
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 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met; * Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately; * The subject or guardian understands and signs the informed consent form; * Expected survival longer than 3 months. Exclusion Criteria: * Severe cardiac insufficiency; * Have a history of severe lung impairment; * Complicated with other advanced malignant tumors; * Complicated with severe or persistent infection that cannot be effectively controlled; * Complicated with severe autoimmune diseases or congenital immune deficiency; * Active hepatitis (HBV DNA or HCV RNA positive); * Human immunodeficiency virus (HIV) infection or syphilis infection; * Have a history of severe allergy to biological products (including antibiotics); * If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation; * Subjects who received CAR-T therapy or other gene modified cell therapy before screening; * Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanxi Bethune Hospital Taiyuan Shanxi Recruiting

More Hebei Senlang Biotechnology Inc., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05618041 on ClinicalTrials.gov ↗ ← All trials in China