NCT06948981 GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
| NCT ID | NCT06948981 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Grit Biotechnology |
| Condition | Hematological Malignancy (Leukemia- Lymphoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2028-04-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2025-04-18 with a primary completion date of 2028-04-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06948981 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hematological Malignancy (Leukemia- Lymphoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06948981 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06948981 currently recruiting?
Yes, NCT06948981 is actively recruiting participants. Contact the research team at zoudehui@ihcams.ac.cn for enrollment information.
Where is the NCT06948981 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06948981 clinical trial?
NCT06948981 is sponsored by Grit Biotechnology. The trial plans to enroll 46 participants.
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