NCT04556669

Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors

Feasibility and Safety of Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labeled, single-armed and prospective study, patients with advanced malignant solid tumors will be given with SL22P autologous CAR - T/CAR-TILs cells. The aim of the study is to evaluate the safety and efficacy of SL22P CAR-T cells, including the adverse reaction, pharmacokinetics, and the outcomes of patients.

Detailed description

SL22P is a proprietary product of Senlang Biotechnology. The T cells may be isolated from the peripheral blood or from the tumor tissue. The CAR-T/CAR-TILs cells contains a anti-CD22 CAR structure and also carries a scFv fragment of anti-PD-L1 monoclonal antibody. After autologous SL22P CAR-T/CAR-TILs cells were transplanted back into patients, CAR-T would target CD22+B cells in the blood. This will promote the activation and amplification of CAR+ cells, and secrete anti-PD-L1 scFv outside the cells to regulate the immunity and enhance anti-tumor activity. The CAR-TILs may reduce the severity of the adverse reactions than conventional TILs, which result from the combination of high dose IL-2 infusion.

Conditions

• Solid Tumor, Adult
• Cervical Cancer
• Sarcoma
• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Autologous aPD-L1 armored anti-CD22 CAR T cells	Autologous aPD-L1 armored CD22-targeting CAR T cells

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-08-01
• Completion: 2025-08-01
• First posted: 2020-09-21
• Last updated: 2021-05-27

Locations

1 site across 1 country: China