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

November 30, 2023 updated by: Allogene Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Texas
      • Austin, Texas, United States, 78704
        • St. Davids South Austin Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLO-647, ALLO-501
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
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days
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
33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allogene Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

October 23, 2021

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-501-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory Follicular Lymphoma

Clinical Trials on ALLO-501

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe