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

Relapsed/Refractory Follicular Lymphoma Clinical Trial

— ALPHA  

Official title:

A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03939026
• Other study ID #: ALLO-501-201
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: Allogene Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: August 2026
• Est. primary completion date: October 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Relapsed/Refractory Follicular Lymphoma
• Relapsed/Refractory Large B Cell Lymphoma

Intervention

Genetic:
• ALLO-501
ALLO-501 is an allogeneic CAR T cell therapy targeting CD19

Biological:
• ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Drug:
• Fludarabine
Chemotherapy for lymphodepletion
• Cyclophosphamide
Chemotherapy for lymphodepletion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allogene Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501	Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion	28 days
Primary	Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501	Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion	33 days