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, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma

Keywords

Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501, ALLO-647, LBCL, Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma, B-Cell Lymphoma, Cyclophosphamide, Fludarabine, ALLO-647, ALLO-501

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
  • Relapse or refractory disease after at least 2 lines of chemotherapy
  • At least 1 measurable lesion at time of screening.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • 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.
  • ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
  • Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
  • Systemic anticancer therapy within 2 weeks prior to study entry.
  • On-going treatment with immunosuppressive agents.
  • Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
  • Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
  • Patients unwilling to participate in an extended safety monitoring period

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allogene Therapeutics
ID
NCT03939026
Phase
Phase 1 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 74 study participants
Last Updated