Lymphomas Clinical Trial
Official title:
A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas
To find the highest tolerable dose of JV-213 (a type of autologous CAR T cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.
Primary Objectives: --The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of JV-213 in patients with r/r B-cell lymphomas. Hypothesis: JV-213 will be safe, well-tolerated, and effective in patients with r/r B-cell lymphomas. Secondary Objectives: --The secondary objective is to determine the efficacy in adults with r/r LBCL and FL grade 3B treated at the MTD or RP2D of JV-213. Although the clinical benefit of JV-213 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Secondary endpoints include overall response rate (ORR; including CR + PR) and CR rate as defined by the Lugano Classification response criteria for malignant lymphoma,53 DOR, PFS, and OS. Hypothesis: JV-213 will induce an ORR of at least 40% in adult subjects with r/r B-cell lymphomas. Exploratory Objectives: --The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of JV-213 anti-CD79b CAR T-cell product and to evaluate biomarkers associated with response, resistance, and toxicity after administration of JV-213 in blood and tumor samples. ;
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