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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUCAR-G39D cells product | Experimental | Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUCAR-G39D cells product | Biological | Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Pharmacokinetics in peripheral blood | CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion. | Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1). |
| Pharmacokinetics in bone marrow | CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion. | Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1) |
| The recommended Phase II dose (RP2D) for this cell therapy | RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion. | Within 30 days after LUCAR-G39D infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LUCAR-G39D cell infusion | Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Response to prior therapy is consistent with one of the following:
Primary refractory.
Relapsed or refractory after 2 or more lines of therapy.
For LBCL, 3B FL. t-iNHL:
Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
7. Pregnant or lactating women;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huilai Zhang | Contact | +86-18622221228 | huilaizhangtz@163.com | |
| Kaiyang Ding | Contact | 13966672170 | dingkaiy@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department, The First Affiliated Hospital of USTC west district | Recruiting | Hefei | Anhui | 230000 | China |
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Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39D to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first |
| Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39D to death of the subject | Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Time to Response (TTR) | Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39D to the date of the first response evaluation of the subject who has met all criteria for CR or PR. | Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Duration of Response (DoR) | Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders. | Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Immunogenicity assessment of LUCAR-G39D cells | The incidence of Anti- LUCAR-G39D antibody in patients who received LUCAR-G39D cells infusion | Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1) |
| Tianjin Cancer Hospital | Recruiting | Tianjin | 300060 | China |
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