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New treatment option for Hematological Malignancy (Leukemia- Lymphoma)
Official title GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
ClinicalTrials.gov ID: NCT06948981
What this study is testing
What is GT719 Injection?
GT719 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hematological malignancy (leukemia- lymphoma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. \-
- Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. \-
- CD19 positivity confirmed by flow cytometry and/or histopathology.
You likely can't join if
- Primary immunodeficiency. \-
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy. \-
- Any medical condition that may interfere with the evaluation of the safety or how well it works of research and treatment;
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.