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TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia

NCT05432401 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-27

No results posted yet for this study

Summary

This is a single arm , open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia. The secondary objectives are as follows: to evaluate the in vivo expansion and persistence of FLT3-targeted chimeric antigen receptor T (CAR-T) cells after injection of TAA05;to evaluate the proportion of FLT3-positive cells in peripheral blood after injection of TAA05;to preliminarily evaluate the efficacy of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia;to evaluate the immunogenicity of TAA05 injection;and to explore the applicable dose in the formal clinical phase.

Conditions

  • FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia

Interventions

BIOLOGICAL

T cell injection targeting FLT3 chimeric antigen receptor

The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10\^8, 2.0 × 10\^8 and 4.0 × 10\^8 CAR-T 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, MD · 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
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2023-06-09
Completion
2025-06-09

Countries

  • China

Study Locations

More Related Trials

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 NCT05432401 on ClinicalTrials.gov