Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Refractory B-cell Non Hodgkin's Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UTAA09 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B cell injection targeting CD19 chimeric antigen receptor
- description
- 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.
- interventionNames
- Biological: UTAA09 injection
Primary outcomes (2)
- measure
- The incidence of dose limiting toxicity (DLT )
- timeFrame
- 28 days after infusion
- description
- The incidence, severity, and types of dose limiting toxicity
- measure
- The incidence of TEAEs
- timeFrame
- 28 days after infusion
- description
- The incidence, severity, and types of adverse events that occur during treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available