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Clinical Trial 20578

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04416984

Phase: Phase I/II
Prinicipal Investigator: Frederick Locke

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Overview

Study Title

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmocodynamics of ALLO-501A, an Anti-CD19 Allogeneic Car T Cell Therapy in Subjects with Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

Summary

The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell 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-501A in successive cohorts of subjects with relapsed/refractory (R/R) LBCL to estimate the maximum tolerated dose (MTD) of ALLO-501A administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647 and to select the recommended Phase 2 dose (RP2D) of ALLO-501A -To assess safety and tolerability of ALLO-647 in combination with Flu/Cy prior to ALLO-501A and to establish the RP2D of ALLO-647. Phase 2: -to assess clinical efficacy of ALLO-501A as measured by overall response rate (ORR) and assessed by Independent Radiology Review (IRR) in subjects with R/R/ LBCL. Secondary Objectives (Phase 1 and 2) -to evaluate the overall safety profile of ALLO-501A and ALLO-647 in combination with Flu/Cy -to evaluate anti-tumor activity of ALLO-501A (Phase 2 only) -To characterize cellular kinetics of ALLO-501A -to characterize the pharmacokinetics of ALLO-647 -to evaluate immunogenicity against ALLO-501A and ALLO-647 -to evaluate host immune cell depletion and reconstitution resulting from lymphodepletion with ALLO-647 in combination with Flu/Cy prior to ALLO-501A Exploratory Objectives (Phase 1 and 2) -to explore potential biomarker development based on assessment of blood cells and tumor cells for ALLO-501A and ALLO-647 -to explore changes in immunoregulatory transcripts (RNA profile) and T cell clonal diversity (TCR DNA sequencing) and its relationship to ALLO-501A expansion, persistence, and activity -to explore the impact of ALLO-501A on systemic soluble immune factors -to collect banked biospecimens for exploratory research, unless prohibited by local regulations or ethics committee decision -to assess MRD negativity -to explore the safety and efficacy of retreatment with ALLO-501A following lymphodepletion

Treatments

Therapies

Medications

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

Inclusion Criteria

  • Histologically confirmed relapsed/refractory large B-cell lymphoma with at least one measurable lesion
  • At least 2 prior lines of chemotherapy including an anthracycline and an anti-CD20 monoclonal antibody
  • Prior CD19 therapy allowed with evidence of CD19 positive relapse following any prior CD19-directed therapy, including cell therapies
  • 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 thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy
  • Prior treatment with any anti-CD52 monoclonal antibody
  • Active acute or chronic graft versus host disease (GVHD)
  • Participants unwilling to participate in an extended safety monitoring period

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