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GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Eligibility criteria expanded, about 6 words
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
  2. Notable Primary endpoint revisedv2 Show 5 more changesShow less
    • Enrollment target: 34 to 46
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study site revised
    • Collaborators expanded, about 8 words
    • Study title revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-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.
Trial Details
NCT Number NCT06948981
Lead Sponsor Grit Biotechnology
Collaborators: Institute of Hematology & Blood Diseases Hospital, China
Conditions
(from sponsor)
Hematological Malignancy (Leukemia- Lymphoma)
Related terms Hematologic Neoplasms
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov