A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Rel… (NCT07205315) | Clinical Trial Compass
RecruitingEarly Phase 1
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
China28 participantsStarted 2025-09-26
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 to 75 years (inclusive), male or female;
* Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;
* Disease progression or recurrence after at least second-line drug treatment;
* CD19 positivity confirmed by flow cytometry and/or histopathology (excluding autoimmune hemolytic anemia);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);
* Expected survival period \> 12 weeks
* For participants with hematological malignancies, the following requirements must be met:
For any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.
For any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.
• For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The tot…
What they're measuring
1
Proportion of participants experiencing dose limiting toxicity
Timeframe: 28 days
2
Incidence and severity of adverse events
Timeframe: From infusion to the end of the treatment at 12 months