GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGrit Biotechnology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
GT719 Injection
Biological/VaccineGT719 Injection
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: GT719 Injection treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From infusion to the end of the treatment at 12 monthsSecondary outcomes
1
Objective response rate
To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator
Time frame
28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Grit Biotechnology
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
Source ClinicalTrials.gov