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Status unknownNCT04692948Updated Mar 8, 2021

TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia

An interventional study of Chimeric antigen receptor T cells (car-t) in CAR and Acute Myeloid Leukemia, sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2019, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a clinical study of TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute Myeloid Leukemia.（TAA6 cell injection is a T cell targeting CD276 chimeric antigen receptor）

Read the detailed description

AML is a malignant disease of myeloid hematopoietic stem / progenitor cells and the most common hematological malignancy. It is characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. In recent years, due to the aging of the population, the incidence of AML and MDS has been on the rise. What is also troubling us is that the incidence of treatment-related MDS and AML in children and adolescents with Hodgkin's disease, sarcoma, breast and testicular tumors, lymphoma and other patients who survive after treatment is also gradually increasing. Occupational exposure such as ionizing radiation and benzene and petrochemical are also related to the incidence of AML.

Car t therapy is the most effective and widely used in the treatment of all. B7-H3, also known as cd276, was first discovered in 2001. It is mainly expressed on the cell surface, such as activated dendritic cells, monocytes, T cells, B cells and NK cells. Studies have shown that B7-H3 can stimulate the expansion and killing of T cells, and may selectively stimulate the signal receptor of T cells. It is a promising target for AML immunotherapy.

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Conditions studied

  • CAR
  • Acute Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 5 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 (including the cut-off value), and the gender was not limited;
  2. The expected survival time ≥ 12 weeks;
  3. ECOG score 0-2;
  4. After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;

  5. The liver and kidney function and cardiopulmonary function meet the following requirements:

    1. Creatinine ≤ 1.5 ULN;;
    2. LVEF ≥ 45%;
    3. Blood oxygen saturation > 91%;
    4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
  6. Able to understand the trial and have signed the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
  2. In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
  3. The patients with HBV (HCV) positive and HBV (HCV) positive in peripheral blood were detected for HBV (HCV) positive Syphilis was positive;
  4. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
  5. Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
  6. Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
  7. Pregnant or lactating women, female subjects planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
  8. Patients who had received car-t therapy or other gene modified cell therapy before screening;
  9. Subjects who were receiving systemic steroid therapy within 7 days before screening or who were judged by the researcher to need long-term systemic steroid therapy during the treatment (except inhalation or local use);
  10. Participated in other clinical studies within 3 months before screening;
  11. There was evidence of central nervous system invasion during screening;
  12. According to the judgment of the researchers, it does not conform to the condition of cell preparation;
  13. Other researchers think that it is not suitable for inclusion.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    TAA6 cell injection

    Drug: TAA6 cell injection（Targeting CD276 autologous chimeric antigen receptor T cells） Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells.Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

    Other: Chimeric antigen receptor T cells (car-t)

Interventions

  • OtherChimeric antigen receptor T cells (car-t)

    Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

    Also known as: TAA6 cell injection

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What researchers measure

Primary outcomes

  1. ORR 3 ORR 3

    3-month objective response rate

    Time frame: three months after CAR-T cells infusion

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Study locations

1 of 1 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui 230000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04692948
Lead sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators
Anhui Provincial Hospital
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Dec 9, 2019
Primary completion
Dec 2021 (estimated)
Completion
Dec 2023 (estimated)
Last update
Mar 8, 2021

Study contacts

Xingbing Wang
Contact
wangxingbing@ustc.edu.cn
13856007984
Huimin Meng
Contact
huimin.meng@persongen.com.cn
0551-65728070
Xingbing Wang
principal investigator · No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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