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

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05618041
Collaborator
(none)
50
1
1
27
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: CAR-T Autologous T cell injection
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
Actual Study Start Date :
Sep 7, 2022
Anticipated Primary Completion Date :
Sep 6, 2024
Anticipated Study Completion Date :
Dec 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAR-T Autologous T cell injection

Patients will be treated with CAR-T cells

Biological: CAR-T Autologous T cell injection
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine;Procedure: Leukapheresis
Other Names:
  • CD19 CAR-T
  • CD20 CAR-T
  • BCMA CAR-T
  • Outcome Measures

    Primary Outcome Measures

    1. Safety: Incidence and severity of adverse events [First 1 month post CAR-T cells infusion]

      To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    2. Efficacy: Remission Rate [3 months post CAR-T cells infusion]

      Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;

    Secondary Outcome Measures

    1. progression-free survival (PFS) [24 months post CAR-T cells infusion]

      progression-free survival (PFS) time

    2. CAR-T proliferation [3 months post CAR-T cells infusion]

      the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method

    3. Cytokine release [1 month post CAR-T cells infusion]

      Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanxi Bethune Hospital Taiyuan Shanxi China

    Sponsors and Collaborators

    • Hebei Senlang Biotechnology Inc., Ltd.

    Investigators

    • Study Director: Jia Wei, MD, Shanxi Bethune Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hebei Senlang Biotechnology Inc., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05618041
    Other Study ID Numbers:
    • 20221019
    First Posted:
    Nov 16, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hebei Senlang Biotechnology Inc., Ltd.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2022