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NCT Number: NCT06904859

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

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shenzhen University General Hospital

Shenzhen, Guangdong, China

About this study

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. T cell receptor (TCR) is a characteristic marker on the surface of T cells. Stimulated by leukemia cell antigens, TCR can produce specific rearrangement and produce specific T cell clones for leukemia. However, immunosuppressive cells and immunosuppressive molecules in the leukemia microenvironment have inhibitory effects on T cells, which reduce the activity of T cells with specific clone proliferation. The anti-tumor effect was weakened. In order to solve this clinical problem, we performed next-generation sequencing analysis of the TCR sequence of an AML patient to find the patient's specific TCR clone against leukemia. The rearranged TCR gene stimulated by leukemia antigen was transduced into the patient's own T cells. To construct TCR gene-modified T cells (TCR-T) that can specifically recognize leukemia antigens and kill leukemia cells, enhance the specificity and killing activity of T cells, and truly realize the individualized treatment of 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Decreased AML percentage in blood

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

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

Secondary outcomes

  1. Decreased AML percentage in cerebrospinal fluid

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

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

Sponsors and collaborators

Lead sponsor

Shenzhen University General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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