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A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 2 sitesv6
  2. Eligibility criteria expanded, about 2 wordsv5
  3. Collaborators: 2 to 3v4
  4. Eligibility criteria expanded, about 466 words
    • Secondary endpoints: 5 to 10
    • Site contacts updated at 1 of 2 sites
    • Study title expanded, about 4 words
    v3
  5. Study sites: 1 to 2
    • Start date changed from estimate of Sep 30, 2025 to Sep 26, 2025
    • Collaborators: 1 to 2
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Grit Biotechnology
30 trials monitored
See 1 trial at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Lymphoblastic Leukemia (ALL)
931 trials monitored
See 58 trials at risk
and 1 more disease
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.
Trial Details
NCT Number NCT07205315
Lead Sponsor Grit Biotechnology
Collaborators: Zhengzhou Yihe Hospital, Institute of Hematology & Blood Diseases Hospital, China, Vivacta Biotechnology (Shanghai) Co., Ltd.
Conditions
(from sponsor)		 B-cell Acute Lymphoblastic Leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL), Autoimmune Hemolytic Anemia (AIHA)
Related terms Anemia, Hemolytic, Autoimmune, Burkitt Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov