RecruitingPhase 2NCT06534060

MB-105 in Patients With CD5 Positive T-cell Lymphoma

A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL).


Sponsor

March Biosciences Inc

Enrollment

46 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests MB-105 — a CAR-T cell therapy targeting a protein called CD5 — in patients with relapsed or refractory T-cell lymphoma (TCL), a rare and often aggressive type of lymphoma that starts in T-cells (immune cells). Because CD5 is found on most T-cell lymphoma cells, CAR-T therapy targeting it may be effective in cancers that have stopped responding to other treatments. This study evaluates safety and initial effectiveness. **You may be eligible if...** - You are 18 or older with T-cell lymphoma (either cutaneous T-cell lymphoma or peripheral T-cell lymphoma) that has relapsed or is refractory - Your tumor tests positive for CD5 protein (at least 50% of cells, or you may qualify for an exploratory group with lower expression) - You have measurable disease on a scan - You have received at least 1 (PTCL) or 2 (CTCL) prior standard treatments - Your heart, lung, kidney, and liver function meet minimum thresholds - Your blood counts are within required ranges **You may NOT be eligible if...** - You had a prior stem cell transplant or CAR-T therapy within the past 60 days - You have active Graft versus Host Disease - You have an active serious infection - You have significant heart or other organ failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGenetic: MB-105

MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.


Locations(12)

University of San Diego (UCSD)-Moores Cancer Center

San Diego, California, United States

SCRI - Colorado Blood Cancer Institute (CBCI)

Denver, Colorado, United States

Moffitt Cancer Center Magnolia Campus

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Nebraska

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregan Health & Science University

Portland, Oregon, United States

Baylor College of Medicine

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06534060


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