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

NCT07205315 | Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-801-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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 and autoimmune hemolytic anemia.

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL); Chronic Lymphocytic Leukemia (CLL); B-cell Non-Hodgkin's Lymphoma (B-NHL); Autoimmune Hemolytic Anemia (AIHA)

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing dose limiting toxicity

  Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion

  28 days

• Incidence and severity of adverse events

  Incidence and severity of adverse events per NCI-CTCAE version 5.0

  From infusion to the end of the treatment at 12 months

Secondary Outcomes (10)

• 3rd month Overall response rate (ORR) of hematological malignancy

  From the date of infusion to the 3rd month

• Best Overall Response (BOR) of hematological malignancy

  Up to 12 months post infusion

• Duration of Response (DoR) of hematological malignancy

  Up to 12 months post infusion

• Progression-free survival (PFS) of hematological malignancy

  Up to 12 months post infusion

• Overall survival (OS) of hematological malignancy

  From the date of infusion to date of death due to any cause, or up to 12 months post infusion (whichever occurs first)

Study Arms (1)

GT801 Injection treatment group

EXPERIMENTAL

GT801 Injection

Biological: GT801 Injection

Interventions

GT801 Injection BIOLOGICAL

GT801 Injection

GT801 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg/m²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g/L at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g/L at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; subcutaneous injection of bortezomib shall be administered for at least 4 times.

You may not qualify if:

• 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;
• Subjects with secondary AIHA induced by drugs or infections;
• Subjects with hereditary hemolytic diseases or other acquired hemolytic diseases.
• 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;
• Administration of hormonal drugs in any form within 14 days prior to infusion (except for AIHA participants requiring such drugs for hemolysis control and those receiving them for preconditioning).
• 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;
• Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year).
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: collaborator
• Zhengzhou Yihe Hospital: collaborator
• Grit Biotechnology: lead
• Vivacta Biotechnology (Shanghai) Co., Ltd.: collaborator

Study Sites (2)

Zhengzhou Yihe Hospital

Zhengzhou, Henan, 450018, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic; Anemia; Autoimmune Diseases

Central Study Contacts

Li Wang

CONTACT

+8613603846919; zlyywl@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)