Investigator Initiated Study to Assess the Safety of Combination of CLS-015 With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive Large B Cell Lymphoma at Lymphodepletion.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel-Aviv Sourasky Medical Center

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

Treatment groups

12 Participants
are divided into 1 treatment group