Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Sign the willing to sign a consent form 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 willing to sign a consent form form; - Expected survival longer than 3 months. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s or congenital immune deficiency; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

CAR-T Autologous T cell injection

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

Locations (1)

Shanxi Bethune Hospital
Taiyuan, Shanxi, China