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.
NCT07361224 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-05-01
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.
Conditions
- Large B-Cell Lymphoma (LBCL)
Interventions
- DRUG
-
rhDNase I
CLS-015 IV infusions after CAR-T infusion done on Days 0,3,6,10 and 15 after CAR-T infusion
Sponsors & Collaborators
-
Tel-Aviv Sourasky Medical Center
lead OTHER_GOV
Principal Investigators
-
Ron Ram, Prof. · Sourasky Medical Center
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2027-02-28
- Completion
- 2028-02-29
Countries
- Israel
Study Locations
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