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.
Recruiting now · Phase 1
Conditions studied: Large B-Cell Lymphoma (LBCL)
In brief
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.
Key facts
- Study ID
- NCT07361224
- Run by
- Tel-Aviv Sourasky Medical Center
- People needed
- 12
- Starts
- 2026-05-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sourasky Medical Center — Tel Aviv, Israel (enrolling)
Full record on ClinicalTrials.gov
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