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B-cell Acute Lymphoblastic Leukemia (B-ALL)Early Phase 1NCT07205315

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 Early Phase 1 study testing GT801 Injection in people with B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Lymphocytic Leukemia (CLL), run by Grit Biotechnology at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Interim analysis conducted when 2 patients complete primary endpoint measurement. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GT801 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesChina
Study dates
26 Sep 2025to 31 Aug 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dehui Zou contact

+8613602100955

zoudehui@ihcams.ac.cn

China2 sites, 1 recruiting

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

    Tianjin, Tianjin Municipality

    Dehui Zou, +8613602100955, zoudehui@ihcams.ac.cn

    Jun Shi

    Recruiting

  • Zhengzhou Yihe Hospital

    Zhengzhou, Henan, 450018

    Active, not recruiting

Other trials in China

About this study

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.

Being tested
GT801 Injection
Medical subject headings
Burkitt Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Anemia, Hemolytic, Autoimmune

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT801 InjectionBiological

    GT801 Injection

Study groups in NCT07205315
Study groupRoleWhat they receive
GT801 Injection treatment groupExperimentalGT801 Injection
Receives: Biological: GT801 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants experiencing dose limiting toxicity

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

    Measured: 28 days

  2. Incidence and severity of adverse events

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

    Measured: 3 months post GT801 infusion

Secondary outcomes (10)

  1. 3rd month Overall response rate (ORR) of hematological malignancy

    The proportion of all evaluable subjects who were determined by the investigators to have achieved confirmed partial remission or complete remission at the third month after treatment initiation

    Measured: From the date of infusion to the 3rd month

  2. Best Overall Response (BOR) of hematological malignancy

    Best Overall Response (BOR) refers to the best therapeutic effect recorded from the start of treatment until disease progression or recurrence.

    Measured: Up to 12 months post infusion

  3. Duration of Response (DoR) of hematological malignancy

    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

    Measured: Up to 12 months post infusion

  4. Progression-free survival (PFS) of hematological malignancy

    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

    Measured: Up to 12 months post infusion

  5. Overall survival (OS) of hematological malignancy

    To evaluate the time from the date of infusion to the date of death due to any cause

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

  6. Overall response rate (ORR) of Autoimmune Hemolytic Anemia (AIHA)

    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

    Measured: Up to 12 months post infusion

  7. Complete Response Rate (CRR) of Autoimmune Hemolytic Anemia (AIHA)

    Complete Remission Rate (CRR) refers to the proportion of evaluable subjects who achieve complete remission following post-treatment assessment.

    Measured: Up to 12 months post infusion

  8. Partial Response Rate (PRR) of Autoimmune Hemolytic Anemia (AIHA)

    Partial Remission Rate (PRR) refers to the proportion of evaluable subjects who achieve partial remission following post-treatment assessment.

    Measured: Up to 12 months post infusion

  9. Disease-Free Recurrence (DFR) of Autoimmune Hemolytic Anemia (AIHA)

    DFR refers to the state where complete remission of the disease is achieved after treatment, all relevant medications are successfully discontinued, and stable disease without recurrence is maintained for a certain period.

    Measured: Up to 12 months post infusion

  10. Time to Response (TTR) of Autoimmune Hemolytic Anemia (AIHA)

    TTR refers to the interval from the start of treatment to the first documentation of a participant achieving a predefined response.

    Measured: Up to 12 months post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start26 Sep 2025
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205315
Sponsor's protocol ID
GRIT-CD-CHN-801-001
Status last verified
Jul 2026
First submitted
25 Sep 2025
Last updated
20 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GT801 Injection in people with B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Lymphocytic Leukemia (CLL), run by Grit Biotechnology at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dehui Zou (+8613602100955, zoudehui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants experiencing dose limiting toxicity (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07205315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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