Phase I Clinical Study on the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Recurrent or Refractory B-cell Non Hodgkin's Lymphoma

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country10 target enrollmentJuly 31, 2024

ConditionsRecurrent or Refractory B-cell Non Hodgkin's Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Enrollment: 10
Locations: 1
Primary Endpoint: The incidence of dose limiting toxicity (DLT )
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

July 31, 2024

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily participate in clinical studies;
•ECOG score 0-1 points;
•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;
•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

•Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
•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);
•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.