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 groupSponsors and collaborators
Source ClinicalTrials.gov