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To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Primary objectives: To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Secondary objectives: To assess the preliminary efficacy of GB5005 in patients with CD19-positive B-NHL; To describe the pharmacokinetic profile of GB5005 and observe its proliferation and persistence in the body; To explore the correlation between the pharmacokinetic characteristics of GB5005 and cytokine release syndrome (CRS) as well as neurological events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection(1 × 10 ^ 6 cells/kg) |
|
| Median dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection(2 × 10 ^ 6 cells/kg) |
|
| Medium to high dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection(3 × 10 ^ 6 cells/kg) |
|
| High dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection(5 × 10 ^ 6 cells/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB5005 CART | Drug | Included patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) | Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival time (RFS) | Recurrence free survival time was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease recurrence or date of death from any cause, whichever occurs first. PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
13:As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated in the protocol (including the follow-up period) or has insufficient compliance with the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xu | Contact | 18750918842 | xubingzhangjian@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xu | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bing Xu | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| Up to 24 months |
| Overall survival(OS) | Overall survival will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. | Up to 24 months |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |