The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 1
Started
2026-09-15
Last updated
2026-06-05
Condition(s) studied
Relapsed/Refractory B-cell Malignancies
Investigational drug(s) / intervention(s)
LVIVO-TaVec122 product
LVIVO-TaVec122 product: Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
Study summary
This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subjects voluntary agreement to provide written informed consent.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. At least one evaluable tumor lesion.
5. Relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.
6. Clinical laboratory values meet screening visit criteria.
7. Adequate organ function.
Exclusion Criteria:
1. Prior antitumor therapy with insufficient washout period.
2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.
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 Human Albumin, 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. Female subjects who were pregnant, breastfeeding.
6. 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 treatment-emergent adverse events (TEAEs) — Through study completion, an average of 2 years after LVIVO-TaVec122 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-TaVec122 infusion (Day 1) CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.
Pharmacokinetics in bone marrow — Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.
The recommended Phase II dose (RP2D) for the treatment of this research — Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1) RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University 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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.