Prizloncabtagene Autoleucel (Prizlon-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma Post FDA Approved CAR T-cell Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Prizloncabtagene Autoleucel: An Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy

Study summary

This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of Prizloncel, an anti-CD19/CD20 chimeric antigen receptor T cells following lymphodepleting chemotherapy in participants with relapsed/refractory (r/r) diffuse large B-cell lymphoma post FDA approved, commercially available CAR T-cell therapy

Approximately 50 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of Prizlon-cel. Participants will be followed for 24 months (approximately 2 years) to evaluate efficacy, safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, and biomarkers. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.

Eligibility

Primary outcome measure(s)

• Overall Response Rate (ORR) — Through Month 24
  ORR, including CR rate and PR rate according to the Lugano Criteria 2014
• Incidence and severity of adverse events (AEs) — Through Month 24
  Evaluate the incidence, severity, and relationship of adverse events following C-CAR168 infusion, graded according to NCI CTCAE Version 6.0.

Trial sites (2)

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