NCT04764513

Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT

Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.

Detailed description

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Ex-vivo expanded γδ T cell infusion	Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10\^6、 1×10\^7 and 5×10\^7 of cells per kg of body weight). Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1.

Timeline

• Start date: 2021-09-12
• Primary completion: 2023-04-01
• Completion: 2025-04-01
• First posted: 2021-02-21
• Last updated: 2022-03-28

Locations

1 site across 1 country: China