Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma
Conditions
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501, ALLO-647, LBCL, Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma
Brief 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.
Interventions
GENETICALLO-501
ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
BIOLOGICALALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
DRUGFludarabine
Chemotherapy for lymphodepletion
DRUGCyclophosphamide
Chemotherapy for lymphodepletion
Sponsors
Allogene Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 | 28 days | Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion |
| Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501 | 33 days | Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion |
Countries
United States
Outcome results
None listed