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)
Safety: Incidence and severity of adverse events — First 1 month post CAR-T cells infusion To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate — 3 months post CAR-T cells infusion Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
Trial sites (1)
Facility
City
Region
Status
Shanxi Bethune Hospital
Taiyuan
Shanxi
Recruiting
More Hebei Senlang Biotechnology Inc., Ltd. trials in China
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.
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