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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.
This is a single-arm, open-label clinical study to evaluate the safety, tolerability and efficacy of LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies. Subjects who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVIVO-TaVec122 product | Experimental | Each subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIVO-TaVec122 product | Biological | Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | 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 LVIVO-TaVec122 infusion (Day 1) |
| Pharmacokinetics in peripheral blood | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion. | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) |
| Pharmacokinetics in bone marrow | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion. | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) |
| The recommended Phase II dose (RP2D) for the treatment of this research | RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) |
| 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 LVIVO-TaVec122 infusion | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LVIVO-TaVec122 to the first documented disease progression or death, whichever occurs first |
| Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) |
| Time to Response (TTR) | Time to Response (TTR) is defined as the time from the date of first infusion of LVIVO-TaVec122 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 2 years after LVIVO-TaVec122 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 2 years after LVIVO-TaVec122 infusion (Day 1) |
| Immunogenicity assessment of LVIVO-TaVec122 infusion | The incidence of Anti-LVIVO-TaVec122 antibody in patients who received LVIVO-TaVec122 infusion | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) |