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

Not Applicable

Recruiting

• Conditions: Hematological Malignancy (Leukemia- Lymphoma)
• Interventions: Biological: GT801 Injection

• Registration Number: NCT07205315
• Lead Sponsor: Grit Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Study Start: 2025-09-26
• Status Verified: 2025-10
• Study First Posted: 2025-10-03
• Last Update Submitted: 2025-11-13
• Last Update Posted: 2025-11-17
• Primary Completion: 2027-11-30
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Aged 18 to 75 years (inclusive), male or female;
• Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) or B-cell lymphoma diagnosed according to the WHO 2016 classification;
• Disease progression or recurrence after at least second-line drug treatment;
• CD19 positivity confirmed by flow cytometry and/or histopathology;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival period > 12 weeks

Exclusion Criteria

• 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;
• Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;
• If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;
• Active hepatitis B and/or active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and/or core antibody but have HBV-DNA test results within the normal range can be included;
• Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;
• Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary/peripheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;
• A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression/systemic disease-modifying agents within the past 2 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT801 Injection treatment group	GT801 Injection	GT801 Injection

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing dose limiting toxicity	28 days	Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence and severity of adverse events	From infusion to the end of the treatment at 12 months	Incidence and severity of adverse events per NCI-CTCAE version 5.0

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	From the date of infusion to the 3rd month	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
Best Overall Response (BOR)	Up to 12 months post infusion	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)	Up to 12 months post infusion	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)	Up to 12 months post infusion	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
Overall survival (OS)	From the date of infusion to date of death due to any cause, or up to 12 months post infusion (whichever occurs first)	To evaluate the time from the date of infusion to the date of death due to any cause

Trial Locations

Locations (2)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin Municipality, China

Zhengzhou Yihe Hospital; 🇨🇳 Zhengzhou, Henan, China