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

NCT05432401 | Unknown Early Phase 1

• 1 other identifier: PG-pCART-TAA05-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• DLT

  Dose limiting toxicity

  About 2 years

• MTD

  Maximum tolerated dose

  About 2 years

Secondary Outcomes (11)

• Assessment of the safety after FLT3-targeted chimeric antigen receptor T cells infusion (Safety)

  About 2 years

• Assessment of pharmacokinetic (about Cmax)

  About 28 days

• Assessment of pharmacokinetic (about Tmax)

  About 28 days

• Assessment of pharmacokinetic (about AUC0-28d)

  About 28 days

• Assessment of pharmacokinetic (about AUC0-90d)

  About 90 days

Study Arms (1)

T cell injection targeting FLT3 chimeric antigen receptor

EXPERIMENTAL

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.

Biological: T cell injection targeting FLT3 chimeric antigen receptor

Interventions

T cell injection targeting FLT3 chimeric antigen receptor BIOLOGICAL

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.

Also known as: TAA05 Injection

T cell injection targeting FLT3 chimeric antigen receptor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years old (inclusive), male or female;
• Expected survival time ≥ 3 months;
• ECOG performance status of 0-2;
• A clear diagnosis of acute myeloid leukemia at screening and positive expression of FLT3 in tumor cells;
• Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment and meet any of the following criteria:
• After AML complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration;
• Initial cases that failed after 2 courses of standard treatment;
• After CR, patients with relapse within 12 months after consolidation and intensive treatment;
• Patients who relapsed after 12 months but did not respond to conventional chemotherapy;
• or more relapses; persistent extramedullary leukemia;
• Coagulation function, liver and kidney function, cardiopulmonary function meet the following requirements:
• Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time≤1.5 ULN;
• Creatinine≤1.5 ULN;
• Left ventricular ejection fraction≥50%, and no pericardial effusion was found on echocardiography, and no clinically significant abnormal bands were found on electrocardiography;
• Indoor baseline oxygen saturation\>92%;

You may not qualify if:

• Subjects with malignant tumors other than acute myeloid leukemia within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
• Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), severe arrhythmia;
• Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
• Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
• Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion;
• Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
• Subjects who have participated in other clinical studies within 1 months prior to screening;
• Subjects who have evidence of central nervous system invasion at screening, such as tumor cells detected in cerebrospinal fluid or imaging suggesting central infiltration;
• Patients with graft-versus-host reaction and need to use immunosuppressants;
• Patients with a history of epilepsy or other central nervous system diseases;
• Patients with primary immunodeficiency disease;
• Conditions not eligible for cell preparation as judged by the investigator;
• Other conditions considered unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Heng Mei, MD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng Mei, MD

CONTACT

13886160811; mayheng@126.com

Huimin Meng, MD

CONTACT

18015580390; huimin.meng@persongen.com.cn

Study Design

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

Model Details: TAA05 Injection

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 27, 2022
• Study Start: June 9, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2025
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

CN (1)