On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma

NCT ID: NCT06503211

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-12-31

Brief Summary

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The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.

Detailed Description

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Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.

Conditions

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Recurrent or Refractory B-cell Non Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

UTAA09 injection
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B cell injection targeting CD19 chimeric antigen receptor

UTAA09 Injection The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\~1 x 1010 CD19-CAR - γδT cells.

Group Type EXPERIMENTAL

UTAA09 injection

Intervention Type BIOLOGICAL

The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\~1 x 1010 CD19-CAR - γδT cells.

Interventions

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UTAA09 injection

The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\~1 x 1010 CD19-CAR - γδT cells.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Subjects voluntarily participate in clinical studies;
2. ECOG score 0-1 points;
3. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
4. At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions\>1.5cm, and the longest diameter of extranodal lesions\>1.0cm.

Exclusion Criteria

1. Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
2. Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
3. Any unstable 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), and severe arrhythmia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xu Huang, Bachelor

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

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PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Fan, Doctor

Role: CONTACT

86-13813976136

Facility Contacts

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Huimin Meng, Doctor

Role: primary

+86-18015580390

Other Identifiers

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UCART-19-002

Identifier Type: -

Identifier Source: org_study_id

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