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Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Primary Purpose

Relapsed/Refractory Acute Myeloid Leukemia

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
gdT cell injection targeting B7-H3 chimeric antigen receptor
Sponsored by
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) Age≥ 18 years old, gender is not limited; (2) expected survival time≥ 3 months; (3) ECOG score 0-1 points; (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression; (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods. (6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements. (7) Be able to understand the trial and have signed the informed consent form. Exclusion Criteria: (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening; (2) Those who test positive for virus and syphilis; (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification≥ grade III), severe arrhythmia; (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening; (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion; (7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use); (8) Have participated in other clinical studies within 1 month before screening; (9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration; (10) Those who have graft-versus-host response and need to use immunosuppressants; (11) Those with a history of epilepsy or other central nervous system diseases; (12) Patients with primary immunodeficiency diseases; (13) situations that other investigators consider unsuitable for enrollment.

Sites / Locations

  • PersonGen Anke Cellular Therapeutice Co., Ltd.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gdT cell injection targeting B7-H3 chimeric atigen receptor

Arm Description

UTAA06 injection

Outcomes

Primary Outcome Measures

Assessment of the safety after UTAA06 injection treatment (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Secondary Outcome Measures

To evaluate anti-tumor activity (overall survival)
Defined as the time from start of UTAA06 UTAA06 infusion therapy to death (due to any cause)
To evaluate anti-tumor activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
To evaluate anti-tumor activity (progression free survival)
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.

Full Information

First Posted
January 16, 2023
Last Updated
January 31, 2023
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05722171
Brief Title
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Official Title
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
Detailed Description
Eligible subjects will receive 1.0×10^8 CAR gdT, 2.0×10^8 CAR gdT, 4.0×10^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gdT cell injection targeting B7-H3 chimeric atigen receptor
Arm Type
Experimental
Arm Description
UTAA06 injection
Intervention Type
Biological
Intervention Name(s)
gdT cell injection targeting B7-H3 chimeric antigen receptor
Other Intervention Name(s)
UTAA06 injection
Intervention Description
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once.
Primary Outcome Measure Information:
Title
Assessment of the safety after UTAA06 injection treatment (Safety)
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
About 2 years
Secondary Outcome Measure Information:
Title
To evaluate anti-tumor activity (overall survival)
Description
Defined as the time from start of UTAA06 UTAA06 infusion therapy to death (due to any cause)
Time Frame
About 2 years
Title
To evaluate anti-tumor activity (duration of response)
Description
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Time Frame
About 2 years
Title
To evaluate anti-tumor activity (progression free survival)
Description
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.
Time Frame
About 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Age≥ 18 years old, gender is not limited; (2) expected survival time≥ 3 months; (3) ECOG score 0-1 points; (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression; (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods. (6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements. (7) Be able to understand the trial and have signed the informed consent form. Exclusion Criteria: (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening; (2) Those who test positive for virus and syphilis; (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification≥ grade III), severe arrhythmia; (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening; (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion; (7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use); (8) Have participated in other clinical studies within 1 month before screening; (9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration; (10) Those who have graft-versus-host response and need to use immunosuppressants; (11) Those with a history of epilepsy or other central nervous system diseases; (12) Patients with primary immunodeficiency diseases; (13) situations that other investigators consider unsuitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heng Mei, Doctor
Phone
+86-13886160811
Email
mayheng@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heng Mei, Doctor
Organizational Affiliation
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
PersonGen Anke Cellular Therapeutice Co., Ltd.
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huimin Meng, Doctor
Phone
+86-18015580390
Email
huimin.meng@persongen.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

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