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Hematological Malignancy (Leukemia- Lymphoma)Early Phase 1NCT07131254

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors

A Early Phase 1 study testing GT719 Injection in people with Hematological Malignancy (Leukemia- Lymphoma), run by Grit Biotechnology at 1 site 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
Search all trials

Trial summary

This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GT719 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
10 Mar 2025to 1 Dec 2027
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

  • 1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
  • 2. Aged 18 to 75 years (inclusive), regardless of gender.
  • 3. Participants with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma diagnosed according to the WHO 2016 classification.
  • 4. CD19 positivity confirmed by flow cytometry and/or histopathology.
  • 5. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
  • 6. Expected survival period > 12 weeks;
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  • 7. For any prior systemic therapy (excluding immune checkpoint inhibitors), at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed before the participant is scheduled to receive the study treatment. For any prior treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 monoclonal antibodies like Pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days (whichever is shorter) must have passed before the participant is scheduled to receive the study treatment.
  • 8. Toxicities caused by prior treatments must be stable and resolved to grade ≤ 1, excluding clinically insignificant toxicities such as alopecia.
  • 9. Have adequate renal, hepatic, pulmonary, and cardiac functions, defined as follows:
  • . Creatinine Clearance (estimated by the Cockcroft-Gault formula) ≥ 60 mL/min;
  • . Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 times the Upper Limit of Normal (ULN);
  • . Total bilirubin ≤ 1.5 mg/dl, excluding participants with Gilbert syndrome;
  • . Cardiac ejection fraction ≥ 50%, no signs of pericardial effusion detected by Echocardiography (ECHO), and no clinically significant abnormalities found on Electrocardiogram (ECG);
  • . No clinically significant pleural effusion;
  • . Baseline oxygen saturation > 92% when measured under room air conditions.
  • 10. Female participants of childbearing potential must have a negative result from a serum or urine pregnancy test. Females who have undergone surgical sterilization or been postmenopausal for at least 2 years are not considered to be of childbearing potential. They must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are strictly prohibited from donating oocytes within 1 year after the infusion of the study treatment during the study period.
  • 11. Male participants who have active sexual life with females of childbearing potential must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment. All male participants are strictly prohibited from donating sperm within 1 year after the infusion of the study treatment during the study period.

Who cannot join

  • 1. Participants with a history of central nervous system (CNS) leukemia/lymphoma, or those with CNS leukemia/lymphoma shown by magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) intracranial imaging during the screening period, or those with detected malignant cells in cerebrospinal fluid or brain metastases.
  • 2. History of testicular leukemia/lymphoma, and imaging examinations during the screening period suggest active testicular leukemia/lymphoma.
  • 3. History of other untreated malignant tumors within the past 5 years or concurrent with the current disease, excluding adequately treated carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or ≤T1 urothelial carcinoma. Participants with prostate cancer undergoing active surveillance are eligible for this study;
  • 4. Hematopoietic stem cell transplantation with curative intent performed within 6 weeks prior to the planned infusion of GT719 cells;
  • 5. For participants with a history of hematopoietic stem cell transplantation, ≤6 months have elapsed since they received allogeneic hematopoietic stem cell transplantation;
  • 6. History of CD19 CAR-T/NK therapy (except for participants who have received GT719 and are eligible for retreatment);
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  • 7. Received systemic glucocorticoid drugs within 7 days before cell infusion, except inhaled glucocorticoids.
  • 8. History of allergic reactions to any components of the drugs intended for use in the study (including but not limited to the study drug GT719 cell infusion preparation, cyclophosphamide, and fludarabine).
  • 9. Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections, or infections requiring management with intravenous (IV) antimicrobial agents;
  • 10. Positive results for any of the following tests: Human Immunodeficiency Virus (HIV) antibody, Treponema pallidum antibody, Cytomegalovirus (CMV) IgM, Epstein-Barr Virus (EBV) IgM;
  • 11. Active hepatitis B and/or active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBc) but with HBV-DNA levels within the normal range may be included;
  • 12. Presence of any indwelling lines or drainage catheters (e.g., percutaneous nephrostomy tubes, indwelling Foley catheters, biliary drainage tubes, or pleural/peritoneal/pericardial catheters). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted;
  • 13. Presence or history of central nervous system (CNS) disorders, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
  • 14. Participants with lymphoma involvement of the cardiac atria or ventricles.
  • 15. Presence of any of the following within 6 months prior to signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV, see Appendix III), angina pectoris, myocardial infarction, cardiomyopathy, stroke (excluding lacunar infarction), coronary/peripheral artery bypass surgery, clinically significant arrhythmias (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (QTc ≥500 ms corrected by the Bazett's method, as specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), poorly controlled diabetes mellitus, pulmonary embolism, diffuse pulmonary lesions, impaired pulmonary function, or any medical condition deemed by the investigator to be unsuitable for participation in this clinical study;
  • 16. Participants for whom urgent treatment is expected or likely to be required within 6 weeks due to ongoing or impending tumor emergencies (e.g., tumor mass effect, tumor lysis syndrome);
  • 17. Primary immunodeficiency.
  • 18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy;
  • 19. Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment;
  • 20. Vaccination with live attenuated vaccines or mRNA vaccines within 8 weeks prior to lymphodepleting conditioning, or inactivated vaccines within 4 weeks prior;
  • 21. Females of childbearing potential who are pregnant or breastfeeding. Females who have undergone sterilization surgery or been postmenopausal for at least 2 years are not considered to be of childbearing potential;
  • 22. Male and female participants who are unwilling to use contraception from the time of informed consent until 6 months after the completion of treatment.
  • 23. Participants who, in the judgment of the investigator, are unlikely to complete all protocol-required study visits or procedures, including follow-up, or to comply with the requirements of study participation;
  • 24. History of autoimmune diseases within the past 2 years that have caused end-organ damage or required systemic immunosuppressive agents/systemic disease-modifying agents (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).

Trial locations and contacts

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

Hongsheng Zhou contact

086-18665730280

hanson_tcm@hotmail.com

China1 site, 1 recruiting

  • Ganzhou City People's Hospital

    Ganzhou, Jiangxi

    Hongsheng Zhou, 18665730280, hanson_tcm@hotmail.com

    Hongsheng Zhou

    Recruiting

Other trials in China

About this study

This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.

Being tested
GT719 Injection
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • GT719 InjectionBiological

    GT719 Injection

Study groups in NCT07131254
Study groupRoleWhat they receive
GT719 Injection treatment groupExperimentalGT719 Injection
Receives: Biological: GT719 Injection

What is being measured

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

  1. Incidence and severity of adverse events (AEs)

    Incidence and severity of Adverse events (AEs) occurring after infusion and their proportion

    Measured: 28 days

  2. Proportion of participants experiencing dose limiting toxicity

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

    Measured: 28 days

Secondary outcomes (9)

  1. overall response rate (ORR)

    3 months overall response rate (ORR)

    Measured: 3 months

  2. Best Overall Response（BOR）

    3 months Best Overall Response（BOR）

    Measured: 3 months

  3. Duration of Response（DOR）

    3 months Duration of Response（DOR）

    Measured: 3 months

  4. Progression-Free Survival（PFS）

    3 months Progression-Free Survival（PFS）

    Measured: 3 months

  5. Overall Survival（OS）

    3 months Overall Survival（OS）

    Measured: 3 months

  6. Time to Maximum Expansion of Infused Cells (Tmax)

    The time point at which the concentration of infused cells in peripheral blood reaches the peak level following product infusion, measured by flow cytometry

    Measured: From the time of infusion up to Month 3

  7. Peak Expansion Level of Infused Cells (Cmax)

    The maximum copy number or cell count of infused cells in peripheral blood after infusion, measured by flow cytometry

    Measured: From the time of infusion up to Month 3

  8. Area Under the Curve of Infused Cells (AUC)

    The area under the concentration-time curve of infused cells in peripheral blood from the time of infusion to the evaluation endpoint, reflecting the total exposure of cells in vivo

    Measured: From the time of infusion up to Month 3

  9. In Vivo Survival Time of Infused Cells

    The duration during which infused cells remain detectable in peripheral blood, defined as the time point when the cell concentration drops to the lower limit of detection

    Measured: From the time of infusion up to Month 12

Timeline

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

  1. First posted20 Aug 2025
  2. Study start10 Mar 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07131254
Sponsor's protocol ID
GRIT-CD-CHN-719-001
Status last verified
Dec 2025
First submitted
26 Jun 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
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 GT719 Injection in people with Hematological Malignancy (Leukemia- Lymphoma), run by Grit Biotechnology at 1 site 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 17 inclusion and 24 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Hongsheng Zhou (086-18665730280, hanson_tcm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (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 NCT07131254.

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 30 Dec 2025.

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