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Trial Title:
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
NCT ID:
NCT05618041
Condition:
Acute Lymphoblastic Leukemia
Lymphoma
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Conditions: Keywords:
CD19,CD20,BCMA
B-ALL/MM/NHL
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Biological
Intervention name:
CAR-T Autologous T cell injection
Description:
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis
Arm group label:
CAR-T Autologous T cell injection
Other name:
CD19 CAR-T
Other name:
CD20 CAR-T
Other name:
BCMA CAR-T
Summary:
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or
refractory hematolymphoid malignancies.
Detailed 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
Criteria for 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 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiwei Tian, MD
Phone:
008613485304136
Start date:
September 7, 2022
Completion date:
December 6, 2024
Lead sponsor:
Agency:
Hebei Senlang Biotechnology Inc., Ltd.
Agency class:
Industry
Source:
Hebei Senlang Biotechnology Inc., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05618041
