Actively Recruiting
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
Led by Grit Biotechnology · Updated on 2026-05-27
28
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
Z
Zhengzhou Yihe Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of GT801 injection in adult patients with relapsed or refractory CD19-positive B-cell blood cancers and autoimmune hemolytic anemia. This early phase 1 clinical study focuses on patients with B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, B-cell non-Hodgkin's lymphoma, and autoimmune hemolytic anemia who have experienced disease progression after at least second-line drug treatments. The study includes an interim analysis after two patients complete the primary endpoint measurement. Participants will receive GT801 injection as the experimental treatment. The study monitors the proportion of participants experiencing dose-limiting toxicities within 28 days and tracks adverse events for three months after infusion. Additionally, secondary outcomes such as overall response rates, duration of response, progression-free survival, and overall survival up to 12 months post-infusion are assessed for hematologic malignancies. For autoimmune hemolytic anemia, response rates, disease-free recurrence, and time to response are also measured over 12 months. During the study, participants will be closely monitored through clinical assessments and safety evaluations, including adverse event tracking for three months and disease response assessments for up to one year. The study requires participants to meet specific eligibility criteria, including confirmed CD19 positivity and prior treatment history. Follow-up evaluations will ensure ongoing safety and measure treatment outcomes, with participation lasting up to 12 months after GT801 infusion.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive), male or female
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, B-cell non-Hodgkin's lymphoma confirmed by WHO 2016 Classification, or autoimmune hemolytic anemia diagnosed by international consensus
- Disease progression or recurrence after at least second-line drug treatment
- CD19 positivity confirmed by flow cytometry or histopathology (excluding autoimmune hemolytic anemia)
- ECOG performance status score of 0-1 (excluding autoimmune hemolytic anemia)
- Expected survival period greater than 12 weeks
- For hematological malignancies: sufficient interval since last systemic or immune checkpoint inhibitor therapy before study treatment
- For autoimmune hemolytic anemia: minimum durations and conditions for prior glucocorticoid, rituximab, immunosuppressive drugs, or other therapies as specified
You will not qualify if you...
- History or current central nervous system leukemia/lymphoma or brain metastases
- Presence of myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases
- Coagulation disorders or high bleeding risk conditions such as disseminated intravascular coagulation, decompensated cirrhosis, or esophagogastric varices
- Severe or life-threatening bleeding within 4 weeks prior to screening or expected within one week after enrollment
- Secondary autoimmune hemolytic anemia caused by drugs or infections
- Hereditary or other acquired hemolytic diseases
- Recent hematopoietic stem cell transplantation within specified time frames
- Hormonal drug use within 14 days before infusion (except for specific AIHA cases)
- Active hepatitis B or C infection unless viral loads are normal
- Central nervous system diseases or autoimmune diseases involving CNS
- Significant cardiovascular, pulmonary, or other medical conditions unsuitable for participation
- Prior gene-modified or gene-edited cellular therapy products
- Autoimmune diseases causing organ damage or requiring systemic immunosuppression within past 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive GT801 Injection to treat relapsed or refractory CD19-positive B-cell hematologic malignancies or autoimmune hemolytic anemia.
1 infusion visit and follow-up visits during the first 28 days
Duration - Up to 12 months post infusion
Participants are monitored for safety and efficacy outcomes up to 12 months after GT801 infusion.
Regular follow-up visits for up to 12 months
Trial Site Locations
Total: 2 locations
1
Zhengzhou Yihe Hospital
Zhengzhou, Henan, China, 450018
Actively Recruiting
2
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
L
Li Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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