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

NCT05731219 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-16

No results posted yet for this study

Summary

Main research purpose： Evaluate the safety and tolerance of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia.

Secondary research purpose： Evaluate the expansion and persistence of gdT cells targeting B7-H3 chimeric antigen receptor after UTAA06 injection administration in vivo; Evaluate the efficacy of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia; Evaluate the content of B7-H3 positive cells in the peripheral blood after administration of UTAA06 injection; Evaluate the immunogenicity of UTAA06 injection.

Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Interventions

BIOLOGICAL

B7-H3 target, CAR gene modified gdT cell injection

After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 108，3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once.

Sponsors & Collaborators

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • He Huang, doctor · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2023-09-26
Completion
2025-09-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731219 on ClinicalTrials.gov