Relapsed/Refractory B-cell Malignancies
Conditions
Keywords
B-cell malignancies
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALLVIVO-TaVec122 product
Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Nanjing Legend Biotech Co.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntary agreement to provide written informed consent. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. At least one evaluable tumor lesion. 5. Relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications. 6. Clinical laboratory values meet screening visit criteria. 7. Adequate organ function.
Exclusion criteria
1. Prior antitumor therapy with insufficient washout period. 2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies. 3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab). 4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator). 5. Female subjects who were pregnant, breastfeeding. 6. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) | 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. |
| Pharmacokinetics in peripheral blood | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion. |
| Pharmacokinetics in bone marrow | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion. |
| The recommended Phase II dose (RP2D) for the treatment of this research | Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) | RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec122 infusion |
| Progression-free survival (PFS) | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | 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 |
| Overall Survival (OS) | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject |
| Time to Response (TTR) | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | 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 |
| Duration of Response (DoR) | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | 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 |
| Immunogenicity assessment of LVIVO-TaVec122 infusion | Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1) | The incidence of Anti-LVIVO-TaVec122 antibody in patients who received LVIVO-TaVec122 infusion |
Countries
China
Outcome results
None listed