NCT05755854

Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors

Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.

Detailed description

To evaluate the safety and in vivo dynamics of allogeneic γ9δ2 T cell in the treatment of recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation patients, and to explore the appropriate therapeutic dose.

Conditions

• Hematologic Diseases

Interventions

Type	Name	Description
BIOLOGICAL	allogeneic γ9δ2 T Cells	dose escalation (3+3) : dose 1 (5 × 10\^7cells/kg) ,dose 2 (1 × 10\^8 cells/kg) ,dose 3 (2 × 10\^8cells/kg)
DRUG	Fludarabine	Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition
DRUG	Cyclophosphamide	Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition
DRUG	Zoredronic acid	Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the dosage of the instruction）（If applicable）

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-03-06
• Last updated: 2023-09-22

Locations

1 site across 1 country: China