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.
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);
Participants with a history of central nervous system leukemia/lymphoma, or those with central nervous system (CNS) leukemia/lymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;
Subjects with myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases;
Subjects with a history of or current comorbidities that cause coagulation disorders and high bleeding risk, such as disseminated intravascular coagulation (DIC), decompensated cirrhosis, esophagogastric varices, etc.;
Subjects who experienced severe bleeding (defined as bleeding uncontrollable by medication or local therapy) within 4 weeks prior to screening, or have life-threatening bleeding (associated with thrombocytopenia) currently, or are expected to require emergency treatment within one week after enrollment;
Single group
GT801 Injection
Biological/VaccineGT801 Injection
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence and severity of adverse events
Incidence and severity of adverse events per NCI-CTCAE version 5.0
3rd month Overall response rate (ORR) of hematological malignancy
The proportion of all evaluable subjects who were determined by the investigators to have achieved confirmed partial remission or complete remission at the third month after treatment initiation
Best Overall Response (BOR) of hematological malignancy
Best Overall Response (BOR) refers to the best therapeutic effect recorded from the start of treatment until disease progression or recurrence.
Duration of Response (DoR) of hematological malignancy
To evaluate the duration from the date that criteria are met for complete response or partial response as assessed by the investigator until the date of disease progression or death due to any cause
Progression-free survival (PFS) of hematological malignancy
To evaluate the time from the date of infusion to the date of disease progression as assessed by the investigator or the date of death due to any cause
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Grit Biotechnology
Lead sponsor
Zhengzhou Yihe Hospital
Collaborator
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
Vivacta Biotechnology (Shanghai) Co., Ltd.
Collaborator
