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
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.
- 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)
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China
- 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