Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase EARLY_PHASE1
Started
2026-01-10
Last updated
2026-02-10
Condition(s) studied
Multiple Myeloma (MM)
Investigational drug(s) / intervention(s)
LVIVO-TaVec400 product
LVIVO-TaVec400 product: Prior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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
Trial sites (6)
Facility
City
Region
Status
Henan Cancer Hospital
Zhengzhou
Henan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Beijing GoBroad Boren Hospital
Beijing
China
Institute of Hematology & Blood Diseases Hospital
Tianjin
China
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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