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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
PersonGen.Anke Cellular Therapeutice Co., Ltd.
RECRUITING
Hefei
Contact Information
Primary
Lei Fan, Doctor
fanlei3014@126.com
86-13813976136
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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