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Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA-2) (ALPHA-2)

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ClinicalTrials.gov Identifier: NCT04416984
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

Study Description
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Brief Summary:
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Large B Cell Lymphoma Genetic: ALLO-501A Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALLO-501A, ALLO-647 Genetic: ALLO-501A
ALLO-501A 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


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501A [ Time Frame: 28 days ]
    Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion

  2. Phase 1: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A [ 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse.
  • At least 1 measurable lesion at time of enrollment.
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • ECOG performance status 0 or 1.
  • Absence of donor (product)-specific anti-HLA antibodies (DSA).
  • Adequate hematological, renal and liver function.

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma.
  • Clinically significant CNS dysfunction
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Radiation therapy within 2 weeks prior to ALLO-647.
  • Prior irradiation to >25% of the bone marrow.
  • Donor lymphocyte infusion (DLI) within 30 days prior to ALLO-647.
  • Patients unwilling to participate in an extended safety monitoring period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416984


Contacts
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Contact: Allogene 415-604-5696 clinicaltrials@allogene.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Jaclyn Hiett    626-256-4673 ext 80697    jhiett@coh.org   
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: April Johnson    310-825-6969    AprilDJohnson@mednet.ucla.edu   
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94035
Contact: Linnea Nichols    650-724-9050 ext 49050    linneab@stanford.edu   
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218-1234
Contact: Kristine Winter    303-577-6491    Kristine.Winter@sarahcannon.com   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sarah Lam    305-243-8143    sxl1585@med.miami.edu   
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612-9416
Contact: Karen Courtier    813-745-5390    karen.courtier@moffitt.org   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Kylee Fleig    502-629-3681    kylee.fleig@nortonhealthcare.org   
United States, Massachusetts
Harvard Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kevin Lindell    617-726-3914    klindell@mgh.harvard.edu   
United States, New York
Montefiore Einstein Center for Cancer Care Recruiting
Bronx, New York, United States, 10467
Contact: Joel Victor    718-920-4826    jvictor@montefiore.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rachael Purri    215-614-1812    rachael.purri@pennmedicine.upenn.edu   
United States, Texas
St. David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Contact: Renee Stojanovic    512-816-6423    renee.stojanovic@sarahcannon.com   
MD Anderson Cancer Center - University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Swapna Johncy    713-792-8251    sjjohncy@mdanderson.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Nicole Raykovich    414-805-8835    nraykovich@mcw.edu   
Sponsors and Collaborators
Allogene Therapeutics
More Information
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Responsible Party: Allogene Therapeutics
ClinicalTrials.gov Identifier: NCT04416984    
Other Study ID Numbers: ALLO-501A-201
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Allogene Therapeutics:
CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
 ALLO-501A
ALLO-647
LBCL
Lymphoma
Large B-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists