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.
- Genetic: ALLO-501
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular
- 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.
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study