Treatment for recurrent CD19 positive adult B-cell cancers
A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
PHASE1; PHASE2 · Grit Biotechnology · NCT06948981
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Grit Biotechnology (industry) |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06948981 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma or B-acute lymphoblastic leukemia.
Not a fit: Patients with primary immunodeficiency or recent history of significant thromboembolic events 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 B-cell malignancies.
How similar studies have performed: While this approach is being explored, similar studies targeting CD19 positive malignancies have shown promise, indicating potential for success.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
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.
Conditions: Hematological Malignancy