Evaluating UTAA09 Injection for Treating 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
This study is testing a new injection called UTAA09 to see if it is safe and effective for people with recurring B-cell non-Hodgkin's lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06503211 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of UTAA09 injection in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma. It is a single-arm, Phase 1 trial that will monitor participants over a 28-day period following a single dose of the investigational drug. The study will also investigate the clinical efficacy of UTAA09 and measure the levels of CD19 positive B cells in the peripheral blood post-administration.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed large B-cell lymphoma or related conditions who have measurable tumor lesions.
Not a fit: Patients who have previously received chimeric antigen receptor therapy or are undergoing long-term systemic steroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphoma.
How similar studies have performed: While this approach is novel, similar studies targeting B-cell malignancies have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- PersonGen.Anke Cellular Therapeutice Co., Ltd. — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Lei Fan, Doctor
- Email: fanlei3014@126.com
- Phone: 86-13813976136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.