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
Phase 1Interventional Study
Large B-Cell Lymphoma (LBCL)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
12 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Government
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 confi…
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
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