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

Completed · Phase 1

Conditions studied: Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT03939026

Run by

Allogene Therapeutics

People needed

50

Starts

2019-05-01

Expected to finish

2025-01-28

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Stanford University — Stanford, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• St. Davids South Austin Medical Center — Austin, Texas, United States
• MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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