RecruitingPhase 1NCT06503211

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

10 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety, tolerability, and effectiveness of a new CAR-T cell therapy called UTAA09 in patients with different types of B-cell lymphoma that have relapsed or stopped responding to standard treatments, where the cancer cells are positive for CD19 and/or CD20. **You may be eligible if...** - You have confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, or indolent lymphoma that has transformed to a more aggressive form - Your cancer tests positive for CD19 and/or CD20 - You have at least one measurable tumor - Your overall health is good (ECOG score 0–1) **You may NOT be eligible if...** - You have previously received CAR-T therapy or other gene-modified cell therapies - You are on long-term systemic steroid therapy - You have significant heart disease (recent heart attack within 6 months, unstable angina, severe heart failure, or serious arrhythmia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUTAA09 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.


Locations(1)

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China

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NCT06503211