GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Recruiting
Phase 1
Phase 2
Interventional Study
Hematological Malignancy (Leukemia- Lymphoma)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 46 (estimated)
- Sponsor
- Grit Biotechnology · Industry
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About This Trial
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 i…
Trial Locations
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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.
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2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
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3. CD19 positivity confirmed by flow cytometry and…
Contacts