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

Primary Purpose

Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CAR-T Autologous T cell injection
Sponsored by
Hebei Senlang Biotechnology Inc., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring CD19,CD20,BCMA, B-ALL/MM/NHL

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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. 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.

Sites / Locations

  • Shanxi Bethune HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T Autologous T cell injection

Arm Description

Patients will be treated with CAR-T cells

Outcomes

Primary Outcome Measures

Safety: Incidence and severity of adverse events
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
Efficacy: Remission Rate
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

progression-free survival (PFS)
progression-free survival (PFS) time
CAR-T proliferation
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Full Information

First Posted
November 8, 2022
Last Updated
December 2, 2022
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05618041
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
September 6, 2024 (Anticipated)
Study Completion Date
December 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
Keywords
CD19,CD20,BCMA, B-ALL/MM/NHL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAR-T Autologous T cell injection
Arm Type
Experimental
Arm Description
Patients will be treated with CAR-T cells
Intervention Type
Biological
Intervention Name(s)
CAR-T Autologous T cell injection
Other Intervention Name(s)
CD19 CAR-T, CD20 CAR-T, BCMA CAR-T
Intervention Description
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine;Procedure: Leukapheresis
Primary Outcome Measure Information:
Title
Safety: Incidence and severity of adverse events
Description
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
Time Frame
First 1 month post CAR-T cells infusion
Title
Efficacy: Remission Rate
Description
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;
Time Frame
3 months post CAR-T cells infusion
Secondary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
progression-free survival (PFS) time
Time Frame
24 months post CAR-T cells infusion
Title
CAR-T proliferation
Description
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Time Frame
3 months post CAR-T cells infusion
Title
Cytokine release
Description
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Time Frame
1 month post CAR-T cells infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengmin Guo
Phone
008618633039369
Email
guoshengmin@senlangbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Wei, MD
Organizational Affiliation
Shanxi Bethune Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Tian, MD
Phone
008613485304136

12. IPD Sharing Statement

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

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