Hematological Malignancy (Leukemia- Lymphoma)Phase 1/2NCT06948981
GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
A Phase 1/2 study testing GT719 Injection in people with Hematological Malignancy (Leukemia- Lymphoma), run by Grit Biotechnology at 1 site in China.
Trial summary
This study is a prospective single-arm open-labled phase I/II 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancy (Leukemia- Lymphoma)
- 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
- 46 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2025to 17 Apr 2028
- Phase
- Phase 1/2
- 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
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- -
- Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
- -
- CD19 positivity confirmed by flow cytometry and/or histopathology.
Who cannot join
- Primary immunodeficiency.
- -
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
- -
- Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Dehui Zou, +8613602100955, zoudehui@ihcams.ac.cn
Dehui Zou
About this study
Official title: A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
This study is a prospective single-arm open-labled phase I/II 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 46 subjects (anticipated) 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 group | Role | What they receive |
|---|---|---|
| GT719 Injection treatment group | Experimental | GT719 Injection Receives: Biological: GT719 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events per CTCAE 5.0
To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
Measured: From infusion to the end of the treatment at 12 months
Secondary outcomes (1)
Objective response rate
To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator
Measured: 28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start18 Apr 2025
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological Malignancy (Leukemia- Lymphoma)Studies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948981
- Sponsor's protocol ID
- GRIT-CD-CHN-719-001-056
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
- ClinicalTrials.gov ID
- NCT06948981
- Acronym / sponsor ID
- GRIT-CD-CHN-719-001-056
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective single-arm open-labled phase I/II 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 46 subjects (anticipated) will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT719 Injection treatment group | Experimental | Biological: GT719 InjectionGT719 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- -
- Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
- -
- CD19 positivity confirmed by flow cytometry and/or histopathology.
Key exclusion criteria (5 listed)
- Primary immunodeficiency.
- -
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
- -
- Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT719 InjectionGT719 Injection | Biological | GT719 Injection treatment group |
Primary outcome
Incidence and severity of adverse events per CTCAE 5.0
Time frame: From infusion to the end of the treatment at 12 months
To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
1 secondary outcome
Objective response rate
Time frame: 28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 5 inclusion and 5 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 18 Sep 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence and severity of adverse events per CTCAE 5.0 (time frame: From infusion to the end of the treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.