NCT06092047

UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.

Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.

Detailed description

A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion. Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies. Secondary objectives: 1. explore the distribution, amplification and survival of UTAA09 cells in vivo after administration of UTAA09 injection; 2. explore the ratio of CD19-positive cells in peripheral blood after administration of UTAA09 injection.

Conditions

• CD19-positive Relapsed or Refractory B-cell Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	UTAA09 cells for infusion	Intravenous injection, dosage:1-10×10\^8 CAR+ γδT cells, Cell concentration: 2×10\^7 cells/mL.
DRUG	Fludarabine	30 mg/m\^2/day×4 days
DRUG	Cyclophosphamide	1000 mg/m\^2/day×3 days

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-07-01
• Completion: 2028-04-01
• First posted: 2023-10-23
• Last updated: 2025-05-16

Locations

1 site across 1 country: China