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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05619861
Other study ID # 2022/11/09
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 27, 2020
Est. completion date December 26, 2023

Study information

Verified date November 2022
Source Hebei Senlang Biotechnology Inc., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors


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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 26, 2023
Est. primary completion date January 26, 2023
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility 1. 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 2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis; 3. Age 14-70 (including boundary value), both male and female; 4. Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG); 5. The results of treatment related antigens were positive; 6. The expected life span is more than 3 months from the date of signing the informed consent;

Study Design


Intervention

Biological:
CAR-T
Patients will receive CAR-T treatment

Locations

Country Name City State
China Cangzhou People's Hospital Cangzhou Hebei

Sponsors (2)

Lead Sponsor Collaborator
Hebei Senlang Biotechnology Inc., Ltd. Cangzhou People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 months post CAR-T cells infusion
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