About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- rhDNase I