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Completed

NCT Number: NCT03939026

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALLO-501

Genetic

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

ALLO-647

Biological

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Fludarabine

Drug

Chemotherapy for lymphodepletion

Cyclophosphamide

Drug

Chemotherapy for lymphodepletion

Primary outcomes

  1. Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501

    Time frame: 28 days

    Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion

  2. Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501

    Time frame: 33 days

    Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

Sponsors and collaborators

Lead sponsor

Allogene Therapeutics

Industry

Registry information

Official study 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

Acronym: ALPHA

Important dates

Study start
2019
Primary completion
2021
Study completion
2025
First posted
May 6, 2019
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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