Clinical Trials in China / NCT07294625
Recruiting
Early Phase 1
A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT07294625 · tracked via the Priya Life Science China tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
LVIVO-TaVec200 product
LVIVO-TaVec200 product: Prior to infusion of the LVIVO-TaVec200 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-TaVec200 in the treatment of relapsed/refractory multiple myeloma.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| The Affiliated Hospital of XUZHOU Medical University | Xuzhou | Jiangsu | Not Yet Recruiting |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | Not Yet Recruiting |
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Official registry record
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.
View NCT07294625 on ClinicalTrials.gov ↗ ← All trials in China