Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 75

Treatment for recurrent CD19 positive adult B-cell cancers

Official title: A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

Run by Grit Biotechnology · NCT06948981 · Data updated 2026-11-12

This study is testing a new injection to see if it can help adults with certain types of B-cell cancers that have come back or didn't respond to other treatments.

More Hematological Malignancy (Leukemia- Lymphoma) trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment46 (estimated)
SponsorGrit Biotechnology
Industry-sponsored
Locations1 site (Tianjin, Tianjin Municipality)
StatusRecruiting
StartedApril 18, 2025
Main results expectedApril 17, 2028
Study endsApril 17, 2028
Registry record updatedSeptember 18, 2026
Trial IDNCT06948981 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma or B-acute lymphoblastic leukemia.

Probably not a fit

Patients with primary immunodeficiency or recent history of significant thromboembolic events may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of GT719 Injection in patients with relapsed or refractory CD19 positive adult B-cell malignancies, specifically B-cell non-Hodgkin lymphoma and B-acute lymphoblastic leukemia. It is a single-arm, open-label study that includes both dose escalation and expansion phases, aiming to enroll a total of 34 subjects. Participants will be monitored for cellular pharmacokinetics and overall treatment response.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have gone: While this approach is being explored, similar studies targeting CD19 positive malignancies have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

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2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

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3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion Criteria:

1. Primary immunodeficiency.

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2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.

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3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;

Where it's running

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
    Tianjin, Tianjin Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.