ClinicalTrials.gov record NCT07205315
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
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This early-phase (Early Phase 1) interventional study evaluates GT801 injection in adults with relapsed or refractory CD19-positive B‑cell hematologic malignancies and autoimmune hemolytic anemia. It is an open-label, single-group treatment study focused first on safety (dose-limiting toxicity and adverse events) and also collects measures of disease response and survival up to 12 months. An interim analysis is planned after two patients complete the primary endpoint.
What it is studying. The study is testing whether giving a single-group GT801 injection is safe and how patients' diseases respond. Key safety measurements include dose-limiting toxicities within 28 days and adverse events measured up to three months; response and survival outcomes are tracked up to 12 months.
What the researchers hope to learn. To evaluate safety (dose-limiting toxicity and adverse events) of GT801; to measure response rates and best overall response, duration of response, progression-free survival, and overall survival for the hematologic malignancies; and to measure response rates, complete/partial response rates, time to response, and disease-free recurrence for AIHA.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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. Interim analysis conducted when 2 patients complete primary endpoint measurement.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- GT801 Injection
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.
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;
- 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).
- 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; participants who are positive for hepatitis C virus (HCV) antibody but with HCV RNA test results within the normal range are eligible for inclusion.
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive GT801 injection(s) as the study treatment and will have close safety monitoring. The first 28 days include focused checks for dose‑limiting toxicities, with adverse‑event monitoring reported through at least 3 months; disease‑response and survival assessments continue for up to 12 months. Participation involves regular clinic visits for examinations and tests as determined by the study team and reporting of side effects. Specific procedures, visit frequency, and any invasive tests will be defined by the study protocol and discussed during informed consent.
How the study is structured. Open-label, single-group interventional study (Early Phase 1). Participants receive GT801 injection and are followed closely for safety (including a 28-day window for dose-limiting toxicities and adverse-event monitoring for three months) and for treatment responses and survival measures for up to 12 months. There is no randomization or masking.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Sep 26, 2025
- Primary completion
- Nov 30, 2027 (estimated)
- Study completion
- Aug 31, 2028 (estimated)
- Target enrollment
- 28 participants (estimated)
- Last updated on registry
- Jul 20, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Grit Biotechnology
- Collaborators
- Zhengzhou Yihe Hospital
- Institute of Hematology & Blood Diseases Hospital, China
- Vivacta Biotechnology (Shanghai) Co., Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Dehui Zou 📞 +8613602100955 ✉ zoudehui@ihcams.ac.cn
Participating sites (2)
- Zhengzhou Yihe HospitalActive Not Recruiting
Zhengzhou, Henan, 450018 · China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Tianjin, Tianjin Municipality · China
- Dehui Zou · +8613602100955 · zoudehui@ihcams.ac.cn
- Jun Shi
- Dehui Zou
- Liang Huang
- Ying Wang
Terms used on this page · explanations by MedicalUpdates.ai
- relapsed/refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- primary endpoint
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- glucocorticoid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- QTc
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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