Clinical trial · Interventional
GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
This study is a prospective single-arm open-labled phase I/II clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.
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 |
|---|---|---|---|
| Hematological Malignancy (Leukemia- Lymphoma) | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GT719 Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GT719 Injection treatment group
- description
- GT719 Injection
- interventionNames
- Biological: GT719 Injection
Primary outcomes (1)
- measure
- Incidence and severity of adverse events per CTCAE 5.0
- timeFrame
- From infusion to the end of the treatment at 12 months
- description
- To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
Secondary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. \- 2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. \- 3. CD19 positivity confirmed by flow cytometry and/or histopathology. Exclusion Criteria: 1. Primary immunodeficiency. \- 2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy. \- 3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
References
Publications (0)
Data not yet available