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-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

Official Title

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
  • At least 1 measurable lesion at time of enrollment
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • ECOG performance status 0 or 1
  • Absence of donor (product)-specific anti-HLA antibodies (DSA)
  • Adequate hematological, renal, and liver function

You CAN'T join if...

  • Active central nervous system (CNS) involvement by malignancy
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Any other active malignancies that required systemic treatment within 3 years prior to enrollment
  • Radiation therapy within 2 weeks prior to ALLO-647
  • Prior irradiation to >25% of the bone marrow
  • Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening
  • Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
  • Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
  • Subjects with active systemic bacterial, fungal, or viral infection requiring systemic treatment (including positive blood cultures within 7 days before starting lymphodepletion)

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allogene Therapeutics
ID
NCT04416984
Phase
Phase 1/2 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 160 study participants
Last Updated