Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT719 Injection treatment group | Experimental | GT719 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT719 Injection | Biological | GT719 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From infusion to the end of the treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator | 28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12 |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dehui Zou | Contact | +8613602100955 | zoudehui@ihcams.ac.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided