Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06503211

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-07-16

10

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate in the clinical study
  • ECOG performance status score of 0 to 1
  • Histologically confirmed diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, or indolent lymphoma transformed into diffuse large B-cell lymphoma
  • Presence of CD19 and/or CD20 positive cells
  • At least one measurable tumor lesion according to Lugano's criteria: intranodal lesion longer diameter > 1.5 cm or extranodal lesion longer diameter > 1.0 cm
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Prior treatment with chimeric antigen receptor therapy or gene modified cell therapy
  • Current systemic steroid therapy or need for long-term systemic steroid therapy during the study (excluding inhalation or local use)
  • Presence of unstable heart disease including unstable angina, myocardial infarction within 6 months before screening, congestive heart failure classified as NYHA class III or higher, or severe arrhythmia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China, 230088

Actively Recruiting

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Research Team

L

Lei Fan, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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