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Trial Title:
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma
NCT ID:
NCT06503211
Condition:
Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
UTAA09 injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
UTAA09 injection
Description:
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.
Arm group label:
B cell injection targeting CD19 chimeric antigen receptor
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Address:
City:
Hefei
Zip:
230088
Country:
China
Status:
Recruiting
Contact:
Last name:
Huimin Meng, Doctor
Phone:
+86-18015580390
Email:
Huiming.Meng@persongen.com.cn
Start date:
July 31, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503211
