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Tests treatment safety and results for Large B-Cell Lymphoma (LBCL)
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.
ClinicalTrials.gov ID: NCT07361224
What this study is testing
What is rhDNase I?
rhDNase I is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for large b-cell lymphoma (lbcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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...
- Active infection requiring antibiotics
- Females only: Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.