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Clinical Trial 19960

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03939026

Phase: Phase I/II
Principal Investigator: Locke, Frederick

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Overview

Study Title

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic Car T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Patients with Relapsed/Refractory Large B-Cell and Follicular Lymphoma

Summary

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Objective

Primary Objectives Phase 1: To assess safety and tolerability at increasing dose levels of ALLO-501 in successive cohorts of patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma to estimate the maximum tolerated dose (MTD) of ALLO-501 administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647, and select the RP2D of ALLO-501. - To assess safety and tolerability of ALLO-647 in combination with Flu/Cy prior to ALLO-501 to confirm the dose of ALLO-647. Phase 2: To assess clinical efficacy of ALLO-501.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

ALLO-501 (); ALLO-647 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
  • Relapse or refractory disease after at least 2 lines of chemotherapy
  • At least 1 measurable lesion at time of screening
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions

  • Exclusion Criteria

  • Current or history of central nervous system (CNS) lymphoma
  • Clinically significant CNS dysfunction
  • ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647
  • Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
  • Systemic anticancer therapy within 2 weeks prior to study entry
  • On-going treatment with immunosuppressive agents
  • Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
  • Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease)
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Patients unwilling to participate in an extended safety monitoring period

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.