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Recruiting Phase 1 NCT07002112

The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies

Trial Parameters

Condition Relapsed/Refractory B-cell Malignancies
Sponsor The First Affiliated Hospital with Nanjing Medical University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-05-23
Completion 2027-06-30
Interventions
LVIVO-TaVec100 product

Brief Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 product in the Treatment of Relapsed/Refractory B-cell Malignancies.

Eligibility Criteria

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. Aged 18-65 years (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. At least one evaluable tumor lesion. 5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications 6. Life expectancy≥ 3 months 7. Clinical laboratory values meet screening visit criteria 8. Adequate organ function; Exclusion Criteria: Subject eligible for this study must not meet any of the following criteria: 1. Prior antitumor therapy with insufficient washout period ; 2. Prior treatment with other autologous cells or gene therapies other than targeting CD19 autologous CAR-T; 3. Patients who

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