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

NCT05722171 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Interventions

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.

Sponsors & Collaborators

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Heng Mei, Doctor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-27
Primary Completion
2023-12-27
Completion
2024-12-27

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 NCT05722171 on ClinicalTrials.gov