Recruiting NCT05618041

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

No phase Interventional Acute Lymphoblastic Leukemia Lymphoma Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: CAR-T Autologous T cell injection.
Who it may be relevant to: Registry conditions: Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma. Basic parameters: 14 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

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

Safety: Incidence and severity of adverse events [Time frame: First 1 month post CAR-T cells infusion]
Efficacy: Remission Rate [Time frame: 3 months post CAR-T cells infusion]

Secondary outcome measures (3)

progression-free survival (PFS) [Time frame: 24 months post CAR-T cells infusion]
CAR-T proliferation [Time frame: 3 months post CAR-T cells infusion]
Cytokine release [Time frame: 1 month post CAR-T cells infusion]

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:

Creatinine ≤ 1.5 × ULN;
Left ventricular ejection fraction ≥ 50%;
Blood oxygen saturation>90%;
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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299. PMID 38062808

NCT: NCT05618041 · 20221019