Back to resultsCAR-T Cells in the Treatment of Malignant Hematological Tumors
Primary Purpose
Lymphoma, B-Cell, Leukemia, B-cell, Leukemia, T-Cell
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring T cells
Eligibility Criteria
With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis; Age 14-70 (including boundary value), both male and female; Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG); The results of treatment related antigens were positive; The expected life span is more than 3 months from the date of signing the informed consent;
Sites / Locations
- Cangzhou People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T
Arm Description
Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg
Outcomes
Primary Outcome Measures
Safety: Incidence and severity of adverse events
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period
Secondary Outcome Measures
Full Information
NCT ID
NCT05619861
First Posted
November 9, 2022
Last Updated
November 9, 2022
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Cangzhou People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05619861
Brief Title
CAR-T Cells in the Treatment of Malignant Hematological Tumors
Official Title
Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
January 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Cangzhou People's Hospital
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 safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors
Detailed Description
Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, Leukemia, B-cell, Leukemia, T-Cell, Multiple Myeloma
Keywords
T cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T
Arm Type
Experimental
Arm Description
Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg
Intervention Type
Biological
Intervention Name(s)
CAR-T
Intervention Description
Patients will receive CAR-T treatment
Primary Outcome Measure Information:
Title
Safety: Incidence and severity of adverse events
Description
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period
Time Frame
24 months post CAR-T cells infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
Age 14-70 (including boundary value), both male and female;
Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG);
The results of treatment related antigens were positive;
The expected life span is more than 3 months from the date of signing the informed consent;
Facility Information:
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Zhang
Phone
15350769826
Email
dagang504@163.com
12. IPD Sharing Statement
Learn more about this trial
CAR-T Cells in the Treatment of Malignant Hematological Tumors
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