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.
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
Hypersensitivity to CLS-015
Evidence of any clinically significant condition, disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Active infection requiring antibiotics
Females only: Pregnant or breastfeeding
Single group
rhDNase I
DrugCLS-015 IV infusions after CAR-T infusion done on Days 0,3,6,10 and 15 after CAR-T infusion
To evaluate the safety and tolerability of CLS-015 in combination with anti CD19 CAR T therapy in subjects with stable/progressive Large B-Cell lymphoma at lymphodepletion when CLS-015 is given in adjuvant setting.
Safety and tolerability of CLS-015 based on adverse events evaluation and recording will be evaluated from screening to the end of study.
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