Treatment for recurrent CD19 positive adult B-cell cancers
Official title: A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Run by Grit Biotechnology · NCT06948981 · Data updated 2026-11-12
This study is testing a new injection to see if it can help adults with certain types of B-cell cancers that have come back or didn't respond to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | April 18, 2025 |
| Main results expected | April 17, 2028 |
| Study ends | April 17, 2028 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT06948981 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma or B-acute lymphoblastic leukemia.
✕Probably not a fit
Patients with primary immunodeficiency or recent history of significant thromboembolic events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of GT719 Injection in patients with relapsed or refractory CD19 positive adult B-cell malignancies, specifically B-cell non-Hodgkin lymphoma and B-acute lymphoblastic leukemia. It is a single-arm, open-label study that includes both dose escalation and expansion phases, aiming to enroll a total of 34 subjects. Participants will be monitored for cellular pharmacokinetics and overall treatment response.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have gone: While this approach is being explored, similar studies targeting CD19 positive malignancies have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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;
Where it's running
-
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Dehui Zou
- Email: zoudehui@ihcams.ac.cn
- Phone: +8613602100955
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.