A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.
U01 (ssCART-19) is positioned to address a significant unmet need in the treatment of relapsed or refractory B-cell lymphoma, a market characterized by high demand for innovative therapies. The asset is currently in Phase 1 clinical trials, with recruitment ongoing at Tongji Hospital in Shanghai, China. The competitive landscape includes established CAR-T therapies such as Kymriah and Yescarta, which have demonstrated efficacy but also present challenges related to safety and tolerability. The incorporation of an IL-6 silencing element may provide a differentiated safety profile, potentially enhancing market acceptance and adoption. Successful outcomes could lead to expedited pathways for regulatory approval, particularly in regions with high incidence rates of B-cell lymphoma.
Indication: B Cell Lymphoma
Modality: cell therapy
Target: CD19-targeted CAR-T cells engineered with an IL-6 silencing element
Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 18, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: CD19-targeted CAR-T cells engineered with an IL-6 silencing element
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Condition raw: B Cell Lymphoma
Condition normalized: B Cell Lymphoma
Modality raw: cell therapy
Modality normalized: cell therapy
Target raw: CD19-targeted CAR-T cells engineered with an IL-6 silencing element
Target normalized: CD19-targeted CAR-T cells engineered with an IL-6 silencing element