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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
GT801 Injection
Zhengzhou Yihe Hospital
Zhengzhou, Henan, China
RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGProportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Time frame: 28 days
Incidence and severity of adverse events
Incidence and severity of adverse events per NCI-CTCAE version 5.0
Time frame: From infusion to the end of the treatment at 12 months
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
Time frame: From the date of infusion to the 3rd month
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.
Time frame: Up to 12 months post infusion
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
Time frame: Up to 12 months post infusion
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
Time frame: Up to 12 months post infusion
Overall survival (OS) of hematological malignancy
To evaluate the time from the date of infusion to the date of death due to any cause
Time frame: From the date of infusion to date of death due to any cause, or up to 12 months post infusion (whichever occurs first)
Overall response rate (ORR) of Autoimmune Hemolytic Anemia (AIHA)
To evaluate the percentage of participants who have a confirmed partial response or complete response among total number of evaluable participants as assessed by the investigator
Time frame: Up to 12 months post infusion
Complete Response Rate (CRR) of Autoimmune Hemolytic Anemia (AIHA)
Complete Remission Rate (CRR) refers to the proportion of evaluable subjects who achieve complete remission following post-treatment assessment.
Time frame: Up to 12 months post infusion
Partial Response Rate (PRR) of Autoimmune Hemolytic Anemia (AIHA)
Partial Remission Rate (PRR) refers to the proportion of evaluable subjects who achieve partial remission following post-treatment assessment.
Time frame: Up to 12 months post infusion
Disease-Free Recurrence (DFR) of Autoimmune Hemolytic Anemia (AIHA)
DFR refers to the state where complete remission of the disease is achieved after treatment, all relevant medications are successfully discontinued, and stable disease without recurrence is maintained for a certain period.
Time frame: Up to 12 months post infusion
Time to Response (TTR) of Autoimmune Hemolytic Anemia (AIHA)
TTR refers to the interval from the start of treatment to the first documentation of a participant achieving a predefined response.
Time frame: Up to 12 months post infusion
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