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

Exclusion Criteria

• •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.
• •6. History of any malignancy within 2 years with the exception of cured stage 1 cancers or CIS and potentially indolent cancers not requiring active treatment or controlled with hormone therapy. Discuss patients with indolent cancers with the medical monitor.
• •7. History of hypersensitivity reactions to products containing murine proteins.
• •8. Active CNS lymphoma.
• •9. Evidence of acute graft versus host disease (aGVHD) \> Grade 2 Mount Sinai Acute GVHD International Consortium (MAGIC) or chronic GVHD \> mild (NIH) requiring ongoing systemic steroids and/or multiagent therapy.
• •10. Patients who have received systemic immunosuppressive therapy for treatment of GVHD within 28 days of leukapheresis.
• •11. Currently requiring systemic corticosteroid therapy (10 mg/day or less of prednisone or equivalent doses of other systemic steroids are allowed for control of non-exclusionary pre-existing conditions). A 2-week washout is required prior to leukapheresis and prior to lymphodepletion for patients on \> 10 mg/day prednisone equivalent.
• •12. Patients who have received donor lymphocyte infusions within 28 days of MB-105 infusion.
• •13. Comorbidity that would impair the patient's ability to receive or tolerate MB-105 and/or affect participation in the study:
• •1. History of cardio- or cerebrovascular disease including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III-IV) within 6 months or cerebrovascular accident (CVA; stroke) within 12 months prior to informed consent.
• •2. History of central nervous system (CNS) disorder(s) such as an uncontrolled seizure disorder, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
• •3. Any serious underlying medical or psychiatric condition deemed by the investigator and medical monitor to be exclusionary due to risk to the patient or to protocol compliance.
• •14. History of autoimmune disorders, including rheumatic diseases and thyroid disorders (though patients with a history of thyroid disease who have undergone successful therapy may be suitable). Exemptions for mild or limited disease may be granted after discussion between the Investigator and sponsor's medical monitor.
• •15. Participated in active treatment on other interventional research clinical trials \< 30 days before enrollment (participation in follow-up permitted). Contact the medical monitor to discuss prior experimental agents targeting the T cell lineage and the appropriate washout period.
• •16. Received bendamustine prior to enrollment (unless received an allo-HSCT in the interim).