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

Phase 1

Recruiting

• Conditions: Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
• Interventions: Biological: UTAA09 injection

• Registration Number: NCT06503211
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-07
• Study First Submitted QC: 2024-07-14
• Last Update Submitted: 2024-07-14
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Study Start: 2024-07-31
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B cell injection targeting CD19 chimeric antigen receptor	UTAA09 injection	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.

Primary Outcome Measures

Name	Time	Method
The incidence of dose limiting toxicity (DLT )	28 days after infusion	The incidence, severity, and types of dose limiting toxicity
The incidence of TEAEs	28 days after infusion	The incidence, severity, and types of adverse events that occur during treatment

Secondary Outcome Measures

Name	Time	Method
OS	24 months after infusion	Evaluate the overall survival based on the efficacy criteria of Lugano 2014
ORR	24 months after infusion	Evaluate the overall response rate based on the efficacy criteria of Lugano 2014
PFS	24 months after infusion	Evaluate the progression free survival based on the efficacy criteria of Lugano 2014

Trial Locations

Locations (1)

PersonGen.Anke Cellular Therapeutice Co., Ltd.; 🇨🇳 Hefei, Anhui, China