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A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Phase: Phase 1/2 to Early Phase 1v2 Show 5 more changesShow less
    • Start date: Sep 25, 2024 to Mar 10, 2025
    • Primary and study completion dates: Sep 24, 2027 to Dec 1, 2027
    • Eligibility criteria expanded, about 752 words
    • Secondary endpoints: 1 to 9
    • Study title expanded, about 14 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This study is a prospective single-arm open-label 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 34 subjects will be enrolled in this study.
Trial Details
NCT Number NCT07131254
Lead Sponsor Grit Biotechnology
Collaborators: Ganzhou City People's Hospital
Conditions
(from sponsor)
Hematological Malignancy (Leukemia- Lymphoma)
Related terms Hematologic Neoplasms
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov