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Clinical Trial 19960

Cancer Type: Malignant Hematology
Interventions:ALLO-501 (); ALLO-647 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Frederick Locke

Call 813-745-6100
or 1-800-679-0775
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 in Patients with Relapsed/Refractory Large B-Cell and Follicular Lymphoma

Summary

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.

Inclusion Criteria

  • Histologically proven relapsed or refractory aggressive large B-cell lymphoma or follicular lymphoma with at least one measurable lesion
  • At least 2 prior lines of therapies including an anthracycline and an anti-CD20 monoclonal antibody
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Absence of donor (product)-specific anti-HLA antibodies
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions

  • Exclusion Criteria

  • Current or history of central nervous system (CNS) lymphoma
  • Clinically significant CNS dysfunction
  • Current or history of thyroid disorder
  • Prior treatment with any anti-CD52 or anti-CD19 therapy, gene therapy, genetically modified cell therapy, or adoptive T-cell therapy
  • Active acute or chronic graft versus host disease (GVHD)
  • History of HIV infection or acute or chronic active hepatitis B or C infection
  • Participants unwilling to participate in an extended safety monitoring period
  • Systemic anti-cancer therapy within 2 weeks prior to study entry. If the last immediate anti-cancer treatment contained an antibody-based agent(s) (approved or investigational), then an interval of 14 days or 5 half-lives (whichever is shorter) of the agent(s) prior to receiving ALLO-647. Participants who received rituximab (an anti-CD20 IgG1 monoclonal antibody binding to ALLO-501¿s off switch) within 9 months of ALLO-501 dose must meet one of the following to be eligible:
  • A serum concentration of rituximab must be ≤1 μg/mL, OR
  • A serum concentration of rituximab ≤15 μg/mL and participant willing to undergo up to 3 plasmapheresis.
  • Participants who received rituximab >9 months from ALLO-501 infusion are eligible and do not require rituximab concentration determination.