NCT04696705

Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients

The Safety and Efficacy Assessment of Ex-Vivo Expanded Allogeneic γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) and Peripheral T Cell Lymphomas (PTCL)

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Detailed description

This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from a blood-related donor of NHL or PTCL patients(except for γδT lymphoma). This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatments and follow-ups. The study will evaluate the safety and efficacy of the ex-vivo expanded allogeneic γδT cells in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Conditions

• Non-Hodgkin's Lymphoma (NHL)
• Peripheral T Cell Lymphoma (PTCL)

Interventions

Type	Name	Description
BIOLOGICAL	Ex-vivo expanded allogeneic γδT cells	Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-12-25
• Completion: 2023-12-25
• First posted: 2021-01-06
• Last updated: 2021-01-06

Locations

1 site across 1 country: China