Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Allogene Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Genetic: ALLO-501
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Nichols
650-724-9050
Recruiting