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.
CLS-015-TAMSC-LBCL-PR An Exploratory, Investigator Initiated Study to Assess the Safety of Combination of CLS-015 (DFF) With Anti-CD-19 CAR-T Cells in Patients With Stable/ Progressive Large B Cell Lymphoma at Lymphodepletion.
Tel-Aviv Sourasky Medical Center
12 participants
May 1, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
Exclusion Criteria4
- 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
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Interventions
CLS-015 IV infusions after CAR-T infusion done on Days 0,3,6,10 and 15 after CAR-T infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07361224