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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
• Intervention / Treatment: Biological: UTAA09 injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lei Fan, Doctor; Phone Number: 86-13813976136; Email: fanlei3014@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Recruiting
      • PersonGen.Anke Cellular Therapeutice Co., Ltd.
      • Contact: Huimin Meng, Doctor; Phone Number: +86-18015580390; Email: Huiming.Meng@persongen.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Evaluate the overall response rate based on the efficacy criteria of Lugano 2014	24 months after infusion
PFS	Evaluate the progression free survival based on the efficacy criteria of Lugano 2014	24 months after infusion
OS	Evaluate the overall survival based on the efficacy criteria of Lugano 2014	24 months after infusion

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Xu Huang, Bachelor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 14, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: UCART-19-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No