RecruitingLymphoma, T-Cell

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

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: March Biosciences Inc

You may qualify if…

✓ 1. Male or female ≥ 18 years of age.
✓ 2. Patients with r/r TCL per WHO 2022 criteria.
✓ 1. r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy.
✓ 2. r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin.
✓ 3. Has available tumor tissue or is willing to undergo a biopsy procedure.
✓ 4. CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT. CD5 positivity is currently defined as having ≥ 50% CD5 expression. An exploratory cohort will enroll patients with CD5 expression below 50%.
✓ 5. Karnofsky performance score ≥ 70% or higher.
✓ 6. Prior CAR T-cell therapy must have occurred \> 60 days prior to study enrollment and must have no evidence of CAR persistence.

You may not qualify if…

✕ 1. 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.
✕ 2. Contraindication to leukapheresis.
✕ 3. Prior treatment with any CD5-targeted therapy.
✕ 4. Any evidence of the following active viral infections:
✕ 1. HIV infection.
✕ 2. Chronic hepatitis B virus (cHBV) infection with detectable viral load. Patients with cHBV, who are receiving anti-viral prophylaxis, may be enrolled if they are asymptomatic for \>5 days prior to signing informed consent (ICF).
✕ 3. Hepatitis C (HCV) infection with detectable viral load. Patients cured of HCV may be enrolled.
✕ 5. Presence of any active, uncontrolled systemic bacterial, viral or fungal infection requiring intravenous (IV) anti-infectives, including clinically significant viral infection or uncontrolled viral reactivation of Epstein-Barr virus, Cytomegalovirus, Adenovirus, BK-virus, or Human herpesvirus 6. If treated with anti-infective agents, patients must be asymptomatic for \>5 days prior to enrollment.