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.

Age: 18 Years and older

Gender: All

Start Date: 05/01/2019

Primary Completion Date (Estimated): 10/23/2021

Study Completion Date (Estimated): 01/28/2025

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts 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