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Brief Title: Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
Official Title: An Open-label, Phase 1/2 Study of Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
Study ID: NCT04765462
Brief Summary: The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.
Detailed Description: This is an open-label, single-center, phase 1/2 study to evaluate the safety, feasibility and efficacy of allogeneic γδ T cell therapy. In phase 1 period, a typical 3+3 dose-escalation design will be used to determine the optimal dose level based on the incidence of dose-limiting toxicity (DLT), which will be recommended as the fixed dose level in the following expansion period and phase 2. The initial infusion dose level will start from 2x10\^6/kg to 5x10\^7/kg in every 2-4 weeks. Combinations with chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and other therapies are allowed in this study depending on the disease status of the enrolled patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Biotherapeutic Department of Chinsese PLA Gereral Hospital, Beijing, Beijing, China
Name: Weidong Han, M.D
Affiliation: Biotherapeutic Department of Chinese PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Yanshan Li
Affiliation: Biotherapeutic Department of Chinese PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Kaichao Feng
Affiliation: Biotherapeutic Department of Chinese PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR