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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	14 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05618041
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hebei Senlang Biotechnology Inc., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jia Wei, MD
Principal Investigator Affiliation	Shanxi Bethune Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma

Additional Details

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

Arms & Interventions

Arms

Experimental: CAR-T Autologous T cell injection

Patients will be treated with CAR-T cells

Interventions

Biological: - CAR-T Autologous T cell injection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanxi Bethune Hospital, Taiyuan, Shanxi, China

Status

Recruiting

Address

Shanxi Bethune Hospital

Taiyuan, Shanxi,

Site Contact

Weiwei Tian, MD

guoshengmin@senlangbio.com

008613485304136

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