Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04556669|
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult Cervical Cancer Sarcoma NSCLC||Biological: Autologous aPD-L1 armored anti-CD22 CAR T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Safety of Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2025|
|Experimental: CD22（aPD-L1）CAR-T cells||
Biological: Autologous aPD-L1 armored anti-CD22 CAR T cells
Autologous aPD-L1 armored CD22-targeting CAR T cells
- safety evaluation [ Time Frame: first three months ]To evaluate the possible adverse reactions recorded within 3 months after SL22P infusion, mainly including the incidence, incidence and severity of skin toxicity, organ toxicity, severe neurotoxicity, cytokine storm and other immunotherapy related toxic reactions (irAEs).
- Tmax of cell metabolism [ Time Frame: first month ]The highest concentration (Cmax) of anti-CD22 CAR-T cells amplified in peripheral blood; the time to reach the highest concentration (Tmax).
- The AUC28d of cell metabolism [ Time Frame: first month ]The according area under the curve at 28 days (AUC28d).
- PFS evaluation [ Time Frame: 12 months ]The researchers evaluated progression-free survival (PFS) according to RECIST V1.1.
- OS evaluation [ Time Frame: 12 months ]The researchers evaluated overall survival (OS) according to RECIST V1.1.
- ORR evaluation [ Time Frame: 12 months ]The researchers evaluated objective remission rate (ORR) according to RECIST V1.1.
- DoR evaluation [ Time Frame: 12 months ]The researchers evaluated remission duration (DoR) according to RECIST V1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556669
|Contact: Zhimeng Qiufirstname.lastname@example.org|
|Fourth Hospital of Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050000|
|Contact: Zhiyu Wang, PhD & MD email@example.com|
|Contact: Jianqiang Li, PhD & MD firstname.lastname@example.org|
|Principal Investigator: Zhiyu Wang, PhD & MD|
|Principal Investigator: Jianqiang Li, PhD & MD|
|Principal Investigator:||Zhiyu Wang||Hebei Medical University Fourth Hospital|