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Clinical Trials in Israel / NCT07361224
Recruiting Phase 1

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 · tracked via the Priya Life Science Israel tracker
Sponsor
Tel-Aviv Sourasky Medical Center
Phase
Phase 1
Started
2026-05
Last updated
2026-05-01

Condition(s) studied

Large B-Cell Lymphoma (LBCL)

Investigational drug(s) / intervention(s)

rhDNase I

rhDNase I: CLS-015 IV infusions after CAR-T infusion done on Days 0,3,6,10 and 15 after CAR-T infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • To evaluate the safety and tolerability of CLS-015 in combination with anti CD19 CAR T therapy in subjects with stable/progressive Large B-Cell lymphoma at lymphodepletion when CLS-015 is given in adjuvant setting. — Through study completion, an average of 2 years.
    Safety and tolerability of CLS-015 based on adverse events evaluation and recording will be evaluated from screening to the end of study.

Trial sites (1)

FacilityCityRegionStatus
Sourasky Medical Center Tel Aviv Israel Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361224 on ClinicalTrials.gov ↗ ← All trials in Israel