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

December 2, 2022 updated by: Hebei Senlang Biotechnology Inc., Ltd.
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
          • Weiwei Tian, MD
          • Phone Number: 008613485304136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Incidence and severity of adverse events
Time Frame: 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
First 1 month post CAR-T cells infusion
Efficacy: Remission Rate
Time Frame: 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;
3 months post CAR-T cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 24 months post CAR-T cells infusion
progression-free survival (PFS) time
24 months post CAR-T cells infusion
CAR-T proliferation
Time Frame: 3 months post CAR-T cells infusion
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
3 months post CAR-T cells infusion
Cytokine release
Time Frame: 1 month post CAR-T cells infusion
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
1 month post CAR-T cells infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Investigators

  • Study Director: Jia Wei, MD, Shanxi Bethune hospital, Shanxi, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Anticipated)

September 6, 2024

Study Completion (Anticipated)

December 6, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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