A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LVIVO-TaVec200 product.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
Overview
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
- Biological LVIVO-TaVec200 product
Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.
Primary outcome measures
- Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)]
- Pharmacokinetics in peripheral blood [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)]
- Pharmacokinetics in bone marrow [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)]
- The recommended Phase II dose (RP2D) for this cell [Time frame: 30 days after LVIVO-TaVec200 infusion]
Eligibility criteria
Inclusion criteria
- 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.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has measurable lesions
- Relapsed and/or refractory multiple myeloma
- Life expectancy≥ 3 months
- Clinical laboratory values meet screening visit criteria
- Adequate organ function.
Exclusion criteria
- Prior antitumor therapy with insufficient washout period ;
- Prior treatment targeting GPRC5D;
- 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).
- 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).
- Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Henan Cancer Hospital — Zhengzhou
- The First Affiliated Hospital with Nanjing Medical University — Nanjing
- The Affiliated Hospital of XUZHOU Medical University — Xuzhou
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an
Identifiers
NCT: NCT07294625 · LB2503-0001