Clinical Trial 23652

• Overview

  Study Title:

  A Phase 1, multicenter, open-label study of UB-VV111 in combination with rapamycin in relapsed/refractory (R/R) CD19+ hematologic malignancies

  Summary:

  This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

  Objective:

  Primary Objectives: To determine the safety profile of UB-VV111 +/- rapamycin in adult subjects with R/R Large B Cell Lymphomas and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of UB-VV111 +/- rapamycin in CAR-naïve and CAR-exposed subjects. Secondary Objective: To assess preliminary antitumor activity of UB-VV111 +/-rapamycin

• Treatments

  Therapies:

  Cell Therapy; mTOR inhibitor

  Medications:

  Rapamycin (Sirolimus); UB-VV111 ()

• Inclusion Criteria

  Inclusion Criteria:
  • 8 years or older
  • Provides voluntary written informed consent
  • Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
  • Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
  • No serious concomitant diseases or active/uncontrolled infections
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Women who are pregnant or breastfeeding
  • Current isolated central nervous system (CNS) involvement
  • Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
  • History of or active human immunodeficiency virus (HIV)
  • Active hepatitis B or C
  • Systemic autoimmune or immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
  • Ongoing CNS disease that would preclude neurologic assessment
  • Uncontrolled angina or other acute heart disease
  • Currently receiving treatment in another interventional clinical trial
  • Other criteria may apply

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