MB-105 in Patients With CD5 Positive T-cell Lymphoma
ConditionLymphoma, T-Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarch Biosciences Inc
About this trial
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 criteria
Qualifiers
Male or female ≥ 18 years of age.
Patients with r/r TCL per WHO 2022 criteria.
r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy.
r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin.
Disqualifiers
Sezary syndrome. For other tumor types, if there is a suspicion of significant circulating disease at time of leukapheresis, discuss eligibility with medical monitor prior to proceeding.
Contraindication to leukapheresis.
Prior treatment with any CD5-targeted therapy.
HIV infection.
Trial design
Treatments tested in this trial
- Genetic: MB-105
Treatment groups
46 Participants
are divided into 1 treatment groupLocations
12California
University of San Diego (UCSD)-Moores Cancer Center92037, San Diego United States
Colorado
SCRI - Colorado Blood Cancer Institute (CBCI)92037, Denver United States
Florida
Moffitt Cancer Center Magnolia Campus33612, Tampa United States
Iowa
University of Iowa52242, Iowa City United States
Sponsors and collaborators
March Biosciences Inc
Lead sponsor
Source ClinicalTrials.gov