NCT04433221

Combination Immunotherapy Targeting Sarcomas

Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.

Detailed description

Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, innovative interventions are needed. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. In addition, studies have shown that low dose chemotherapy such as doxorubicin may modulate surface PD-L1 level and enhance immunotherapy effects. This study will combine multiple CAR T cells with low dose chemotherapy to treat sarcoma, and followed by maintenance sarcoma vaccines. The purpose of this clinical trial will assess the feasibility, safety, efficacy and side effects of this combination therapy in patients who have sarcoma that is relapsed or late staged.

Conditions

• Sarcoma
• Osteoid Sarcoma
• Ewing Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	Multiple sarcoma-specific CAR-T cells and sarcoma vaccines	1 infusion, CART 1x10\^6\~1x10\^7 cells/kg via IV and vaccines 1-5x10\^6 irradiated cells via subcutaneous injection

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-05-31
• Completion: 2023-12-31
• First posted: 2020-06-16
• Last updated: 2020-06-16

Locations

2 sites across 1 country: China