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

Phase 1

Active, not recruiting

• Conditions: Relapsed/Refractory Large B Cell Lymphoma; Relapsed/Refractory Follicular Lymphoma
• Interventions: Genetic: ALLO-501; Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT03939026
• Lead Sponsor: Allogene Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-04
• Study Start: 2019-05-01
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Primary Completion: 2021-10-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLO-647, ALLO-501	ALLO-501	-
ALLO-647, ALLO-501	Cyclophosphamide	-
ALLO-647, ALLO-501	ALLO-647	-
ALLO-647, ALLO-501	Fludarabine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Stanford University; 🇺🇸 Stanford, California, United States

St. Davids South Austin Medical Center; 🇺🇸 Austin, Texas, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States