Clinical trial NCT05618041: The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients with Hematological Malignancies
Official title: The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients with Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Lymphoma
Multiple Myeloma
Keywords: CD19,CD20,BCMA
B-ALL/MM/NHL
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 42
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief 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

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.

Primary outcomes:
measure: Safety: Incidence and severity of adverse events
timeFrame: First 1 month post CAR-T cells infusion
measure: Efficacy: Remission Rate
timeFrame: 3 months post CAR-T cells infusion
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 24 months post CAR-T cells infusion
measure: CAR-T proliferation
timeFrame: 3 months post CAR-T cells infusion
measure: Cytokine release
timeFrame: 1 month post CAR-T cells infusion
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
affiliation: Shanxi Bethune Hospital
name: Jia Wei, MD
role: STUDY_DIRECTOR
References: