RhDNase I

CLS-015 IV infusions after CAR-T infusion done on Days 0,3,6,10 and 15 after CAR-T infusion

Disease progression in large B-cell lymphoma is a major obstacle to successful CAR-T therapy, with approximately 40% of patients experiencing disease progression within 3 months of CAR-T infusion and 60% of patients experiencing disease progression within the first year.

While patients with large B-cell lymphoma in partial response or complete response during lymphodepletion have a progression-free survival (PFS) of 60-80% at 1 year, patients with stable disease (SD) or progressive disease (PD) in the lymphodepletion phase have a poor PFS of 20-30%.

This is a Phase 1, single-center, open-label study to evaluate the safety of CLS-015 in combination with anti-CD19 CAR-T therapy in patients with large B-cell lymphoma. The goal is to improve clinical response by reversing the negative effects of NETs on immune function and CAR-T cells.

Live record on ClinicalTrials.gov →

• Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
• Large B-Cell lymphoma treated with CAR-T targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel)
• Stable Disease or Progressive Disease confirmed by PET-CT on the day of lymphodepletion
• Capable of giving signed informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.