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 2026-04-23
28
Participants Needed
2
Research Sites
152 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
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
Official 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
- Diagnosis of relapsed or refractory acute B-cell lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), B-cell non-Hodgkin's lymphoma (B-NHL) confirmed by WHO 2016 Classification, or autoimmune hemolytic anemia (AIHA) diagnosed by international consensus
- Disease progression or recurrence after at least second-line drug treatment
- CD19 positivity confirmed by flow cytometry and/or histopathology (except for AIHA patients)
- ECOG performance status score of 0-1 (except for AIHA patients)
- Expected survival period greater than 12 weeks
- For hematological malignancies: at least 2 weeks or 5 half-lives since last systemic therapy (excluding immune checkpoint inhibitors), or at least 3 half-lives or 28 days since last immune checkpoint inhibitor treatment
- For AIHA patients: at least 3 months of glucocorticoid therapy (unless intolerance), rituximab administered at least 4 times (100 mg or 375 mg/m2) or at least 2 times (1000 mg per dose) with hemoglobin below 100 g/L at 12 weeks after first dose; at least 4 months of oral immunosuppressive drugs or discontinued due to intolerance; at least 2 cycles of intravenous fludarabine or cyclophosphamide; at least 4 subcutaneous injections of bortezomib
You will not qualify if you...
- History or presence of central nervous system leukemia/lymphoma or brain metastases confirmed by MRI, PET-CT, or cerebrospinal fluid analysis
- Myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases
- History of or current coagulation disorders causing high bleeding risk, such as disseminated intravascular coagulation, decompensated cirrhosis, or esophagogastric varices
- Severe or life-threatening bleeding within 4 weeks before screening or expected within 1 week after enrollment
- Secondary autoimmune hemolytic anemia caused by drugs or infections
- Hereditary hemolytic diseases or other acquired hemolytic diseases
- Hematopoietic stem cell transplantation within 12 weeks before planned GT801 infusion or allogeneic transplantation within 6 months
- Hormonal drug administration within 14 days before infusion except for AIHA patients needing hemolysis control or preconditioning
- Active hepatitis B or C infection (HCV RNA positive), except controlled cases with normal HBV-DNA or HCV RNA levels
- Central nervous system diseases such as epilepsy, cerebrovascular events, dementia, cerebellar diseases, or CNS autoimmune diseases
- Uncontrolled cardiovascular, pulmonary, metabolic, or other serious medical conditions within 6 months prior to consent
- Prior gene-modified or gene-edited cellular therapy, except autologous immune cell therapy without gene modification given more than 1 year ago
- History of 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here