GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06948981

Enrollment

Registered

2025-04-29

Start date

2025-04-18

Completion date

2028-04-17

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancy (Leukemia- Lymphoma)

Brief 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 leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.

Interventions

BIOLOGICALGT719 Injection

GT719 Injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. \- 2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. \- 3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion criteria

1. Primary immunodeficiency. \- 2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy. \- 3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;

Design outcomes

Primary

Measure	Time frame	Description
Incidence and severity of adverse events per CTCAE 5.0	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

Secondary

Measure	Time frame	Description
Objective response rate	28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12	To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator

Countries

China

Contacts

CONTACTDehui Zou

zoudehui@ihcams.ac.cn+8613602100955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026