Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed / Refractory Large B Cell or Follicular Lymphoma

Status: Active

Description

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.

Eligibility Criteria

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
  • Patients unwilling to participate in an extended safety monitoring period

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: April Johnson
Phone: 949-653-2959ext118
Email: AprilDJohnson@mednet.ucla.edu
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Jeff Edelman
Phone: 813-745-1040
Email: jeffrey.edelman@moffitt.org

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Allogene Therapeutics

Trial IDs

Primary ID ALLO-501-201
Secondary IDs NCI-2019-03206
Clinicaltrials.gov ID NCT03939026