Multiple Myeloma (MM)
Conditions
Keywords
Relapsed/Refractory multiple myeloma
Brief summary
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 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-TaVec400 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-TaVec400 product
Prior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
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 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. 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). 3. Those who have experienced life-threatening allergic reactions, hypersensitivity reactions or intolerances to the excipients and related additives of the investigational drug; or those with a previous history of severe allergic reactions (such as hypersensitivity reactions, or those for whom the investigator assesses the need to use glucocorticoids to prevent severe immune-related reactions such as allergic reactions). 4. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study. 5. Also enrolled in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment. | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | — |
| Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial. | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | — |
| Pharmacokinetics in peripheral blood | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec400 infusion |
| Pharmacokinetics in bone marrow | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec400 infusion |
Countries
China
Contacts
CONTACTGang An
CONTACTJianling Yao
PRINCIPAL_INVESTIGATORLugui Qiu
Institute of Hematology & Blood Diseases Hospital, China
Outcome results
None listed