CAR-T Cells in the Treatment of Malignant Hematological Tumors

Sponsor

Hebei Senlang Biotechnology Inc., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05619861

Collaborator

Cangzhou People's Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, B-Cell Leukemia, B-cell Leukemia, T-Cell Multiple Myeloma	Biological: CAR-T	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor

Actual Study Start Date :

Apr 27, 2020

Anticipated Primary Completion Date :

Jan 26, 2023

Anticipated Study Completion Date :

Dec 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAR-T Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg	Biological: CAR-T Patients will receive CAR-T treatment

Arm

Intervention/Treatment

Experimental: CAR-T

Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg

Biological: CAR-T

Patients will receive CAR-T treatment

Outcome Measures

Primary Outcome Measures

Safety: Incidence and severity of adverse events [24 months post CAR-T cells infusion]
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;