Clinical Trial 23320

• Overview

  Study Title:

  A Phase 2, Open-label, Multicenter Study of MB-105 in Patients with CD5 Positive (CD5+) Relapsed/Refractory T-cell Lymphoma (r/r TCL)

  Objective:

  Primary Objectives: Safety Run-In -Confirm safety and tolerability of the recommended dose of MB-105 in r/r TCL in a safety run-in Simon Stage 1 and 2 -Evaluate the anti-tumor efficacy of MB-105 in patients with r/r/ TCL Secondary Objectives: -Further characterize anti-tumor efficacy of MB-105 -Assess durability of therapeutic effect -Further characterize safety and tolerability of MB-105 -Evaluate longer-term impact of MB-105 on patients with r/r TCL -Demonstrate successful manufacturing of MB-105 Exploratory Objectives: -Investigate impacts of MB-105 CAR T on the immune system -Assess potential of MB-105 as a "bridge to transplant" in r/r TCL

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  MB-105 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Male or female ≥ 18 years of age.
  • Patients with r/r TCL per WHO 2022 criteria.
  • Has available tumor tissue or willing to undergo biopsy procedure.
  • CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT.
  • Karnofsky performance score ≥ 70% or higher.
  • Prior CAR T-cell therapy must have occurred > 60 days prior to study enrollment and must have no evidence of CAR persistence.
  • Measurable or detectable disease
  • Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) must have occurred more than 60 days prior to study enrollment.
  • Adequate bone marrow function
  • For females of childbearing potential (defined as > 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.
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • 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.
  • 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.
  • History of other cancer unless disease-free survival ≥ 2 years (cured non-melanoma skin cancer, in situ breast, non-muscle-invasive bladder or in situ cervical cancer are eligible to enter the trial without time limitations).
  • History of hypersensitivity reactions to products containing murine proteins.
  • Active CNS lymphoma.
  • 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.
  • Patients who have received systemic immunosuppressive therapy for treatment of GVHD within 28 days of leukapheresis.
  • 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.
  • Patients who have received donor lymphocyte infusions within 28 days of MB-105 infusion.
  • Comorbidity that would impair the patient's ability to receive or tolerate MB-105 and/or affect participation in the study.
  • 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.
  • Participated in active treatment on other interventional research clinical trials > Additional criteria may apply.

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