NCT05722171

Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.

Detailed description

Eligible subjects will receive 1.0×10\^8 CAR gdT, 2.0×10\^8 CAR gdT, 4.0×10\^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	gdT cell injection targeting B7-H3 chimeric antigen receptor	The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once.

Timeline

• Start date: 2022-12-27
• Primary completion: 2023-12-27
• Completion: 2024-12-27
• First posted: 2023-02-10
• Last updated: 2023-02-10

Locations

1 site across 1 country: China