MB-105 for CD5 Positive T-cell Lymphoma

This study is testing a new treatment called MB-105 for people with CD5 positive T-cell lymphoma that has come back or not responded to previous treatments (relapsed/refractory T-cell lymphoma). MB-105 is a type of CAR T-cell therapy, which uses your own T-cells (a type of immune cell) that have been specially modified to fight cancer. The study aims to see how safe MB-105 is and how well it shrinks tumors. You might be able to join if you are 18 or older and have T-cell lymphoma that meets specific criteria for prior treatments. The study plans to enroll 46 participants, but the current recruitment status is unclear.

Study design
This is a single-arm, open-label, Phase 2 study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to enroll 46 participants in total.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for adverse events and objective response for 26 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06534060

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
March Biosciences Inc
~46 participants
Updated 2025-10-03 on ClinicalTrials.gov
What's tested:Genetic: MB-105

At a glance

Recruiting sites
9 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured over 26 months
+1 more outcome measured
Lymphoma, T-Cell

NCT06534060

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Moffitt Cancer Center Magnolia Campus

    Tampa, Floridastudy coordinator listed

    Recruiting

  • University of Iowa

    Iowa City, Iowastudy coordinator listed

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • University of San Diego (UCSD)-Moores Cancer Center

    San Diego, Californiastudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Alice Bexon, MD, CMO · STUDY_CHAIR · March Bio

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Eligibility criteria

Inclusion

Total bilirubin \< 1.5 x ULN (\< 2 × upper limit of normal (ULN)) if liver involvement).
If no liver involvement and total bilirubin ≥1.5 x ≤ ULN, direct bilirubin \< ULN (Gilbert syndrome)
Aspartate aminotransferase / alanine aminotransferase \< 3 × ULN (5 x ULN if liver involvement).
Albumin \> 2.5 g/dL. 11. For females of childbearing potential (defined as \< 24 months of amenorrhea or not surgically sterile \[absence of ovaries and/or uterus\]), a negative serum pregnancy test must be documented at screening, and prior to lymphodepletion (conditioning). 12. For females of childbearing potential and males, a highly effective method of contraception together with a barrier method must be used from the start of lymphodepletion (conditioning) and for at least 12 months after the last dose of study agent.
  • Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.026 months

    Incidence, severity, causal relationship of AEs

  • Objective response rate (ORR)26 months

    Best objective response rate (ORR) per independent central review as defined by rate of complete response (CR) and PR using the 2014 Lugano criteria and 2022 Global criteria.