Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07361224

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.

Led by Tel-Aviv Sourasky Medical Center · Updated on 2026-05-01

12

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be at least 18 years old at the time of consent
  • Diagnosed with large B-cell lymphoma treated with CAR-T therapy targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel)
  • Have stable disease or progressive disease confirmed by PET-CT on the day of lymphodepletion
  • Able to provide signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Not Eligible

You will not qualify if you...

  • Allergic reaction or hypersensitivity to CLS-015
  • Any clinically significant condition or disease that poses risk to safety or interferes with study participation, as judged by the investigator
  • Active infection that requires antibiotic treatment
  • Pregnant or breastfeeding females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sourasky Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

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Research Team

R

Ron Ram, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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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. | DecenTrialz