Multiple Myeloma
Conditions
Keywords
Relapsed/Refractory multiple myeloma
Brief summary
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 in the treatment of relapsed/refractory multiple myeloma.
Detailed description
This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec200 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject 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-TaVec200 product
Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.
Sponsors
Nanjing Legend Biotech Co.
The First Affiliated Hospital with Nanjing Medical University
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 voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Has measurable lesions 5. Relapsed and/or refractory multiple myeloma 6. Life expectancy≥ 3 months 7. Clinical laboratory values meet screening visit criteria 8. Adequate organ function.
Exclusion criteria
1. Prior antitumor therapy with insufficient washout period ; 2. Prior treatment targeting GPRC5D; 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 DMSO; 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. 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 TEAEs (Treatment-emergent Adverse Events) | Through study completion, an average of 2 years after LVIVO-TaVec200 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-TaVec200 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec200 infusion |
| Pharmacokinetics in bone marrow | Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec200 infusion |
| The recommended Phase II dose (RP2D) for this cell | 30 days after LVIVO-TaVec200 infusion | RP2D established through BF-BOIN design and the DLTs occurring following LVIVO-TaVec200 infusion |
Countries
China
Contacts
Primary ContactLijuan Chen
Backup ContactXuxing Shen
Outcome results
None listed