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

Allogene Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Relapsed/Refractory Follicular Lymphoma; Relapsed/Refractory Large B Cell Lymphoma

Treatments: Genetic: ALLO-501; Drug: Fludarabine; Biological: ALLO-647; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03939026

ALLO-501-201

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

ALLO-647, ALLO-501

Experimental group

Treatment:

Drug: Cyclophosphamide

Biological: ALLO-647

Genetic: ALLO-501

Drug: Fludarabine