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

Hebei Senlang Biotechnology

Status

Enrolling

Conditions

Multiple Myeloma

Lymphoma

Acute Lymphoblastic Leukemia

Treatments

Biological: CAR-T Autologous T cell injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05618041

20221019

Details and patient eligibility

About

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

Full description

Main research purposes:

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

Secondary research purposes:

Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies

Enrollment

50 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

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.