Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Single-Arm, Open-Label, Phase 1 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 Lymphoma or Follicular Lymphoma

Keywords

Relapsed/Refractory Large B Cell Lymphoma Relapsed/Refractory Follicular Lymphoma Lymphoma Lymphoma, Follicular Lymphoma, B-Cell Cyclophosphamide Fludarabine ALLO-501 ALLO-647 ALLO-647, ALLO-501

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allogene Therapeutics
ID
NCT03939026
Phase
Phase 1
Study Type
Interventional
Last Updated