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

Trial Status: Active

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.

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 for large B-cell lymphoma and an anti-CD20 monoclonal antibody for follicular lymphoma
  • 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 or any anti-CD19 therapies that include the 4G7 scFv clone
  • Active acute or chronic graft versus host disease (GVHD)
  • Patients unwilling to participate in an extended safety monitoring period

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: April Johnson
Phone: 949-653-2959ext118
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Jeff Edelman
Phone: 813-745-1040

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Allogene Therapeutics

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