The Role and Mechanism of TCR-T Cells in Immunotherapy for Acute Myeloid Leukemia

NCT06904859 | Completed Early Phase 1 DMC

• 1 other identifier: HEM-ONCO-029
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Acute myeloid leukemia (AML) is the main type of leukemia, accounting for about 60% of all leukemia, with complex pathogenesis and great clinical heterogeneity. Effective targets for AML need to be further developed. We performed next-generation sequencing analysis of the TCR sequence of an AML patient to find the patient's specific TCR clone for leukemia. The rearranged TCR gene stimulated by leukemia antigens was transduced into the patient's own T cells, and the TCR gene-modified T cells (TCR-T) that could specifically recognize leukemia antigens and kill leukemia cells were constructed. Enhancing the specificity and killing activity of T cells can truly achieve individualized treatment for patients. In addition, through TCR sequencing, the TCR sequence database of leukemia patients can be constructed to find the common specific TCR clones for AML among different patients, which can realize the precise treatment of AML.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Hematologic Diseases; Leukemia; Leukemia, Myeloid; TCR gene-modified T cells; immunotherapy; TCR-T cells

Outcome Measures

Primary Outcomes (1)

• Decreased AML percentage in blood

  TCR-T Cells were infused back into the patients then the decreased percentage of AML tumor cells in blood after infusion was measured

  From date of initial treatment to the 20 days after TCR-T Cells infusion

Secondary Outcomes (1)

• Decreased AML percentage in cerebrospinal fluid

  From date of initial treatment to the 20 days after TCR-T Cells infusion

Study Arms (1)

AML patients group

EXPERIMENTAL

To construct TCR sequence database of acute myeloid leukemia patients, and then to verify the effect and mechanism of immunotherapy in vitro and in mice，then TCR gene-modified T cells were infused back into the patients

Biological: TCR-T Cells Injection

Interventions

TCR-T Cells Injection BIOLOGICAL

The TCR sequences of AML patients were analyzed by next generation sequencing to find the specific TCR clone against leukemia，then TCR gene-modified T cells were infused back into the patients

AML patients group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 (≥ 18 years old, ≤ 65 years old)
• gender is not limited
• Acute myeloid leukemia patients
• CR(remission phase, white blood cell count \> 2×10\^9/L after blood picture recovery)
• After 3-4 courses of chemotherapy (the number of courses is not absolute)
• Before the next chemotherapy

You may not qualify if:

• Transformed acute myeloid leukemia
• Secondary acute myeloid leukemia
• Post-transplantation acute myeloid leukemia
• AML-M3
• white blood cell count \<2×10\^9/L
• More than 8 courses of chemotherapy
• Combined with other immune-related diseases
• Pregnancy

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Hematologic Diseases; Leukemia; Leukemia, Myeloid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 1, 2025
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2020
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)