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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416984
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 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

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




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

  3. Phase 2: Overall Response Rate [ Time Frame: up to 13 months ]
    Overall response rate assessed by independent radiology review


Secondary Outcome Measures :
  1. Phase 1 and 2: Incidence and severity of adverse events with ALLO-501A and ALLO-647 in combination with fludarabine/cyclophosphamide [ Time Frame: up to 13 months ]
  2. Phase 1 and 2: Cellular kinetics of ALLO-501A in target tissues [ Time Frame: up to 13 months ]
    Levels of Anti-CD19 CAR T cells in blood

  3. Phase 1 and 2: Pharmacokinetics of ALLO-647 [ Time Frame: up to 13 months ]
    Serum concentration levels of ALLO-647

  4. Phase 1 and 2: Immunogenicity against ALLO-501A and ALLO-647 [ Time Frame: up to 13 months ]
    Detection of antibodies in blood against ALLO-501A and ALLO-647

  5. Phase 1 and 2: Immune monitoring after lymphodepletion regimen [ Time Frame: up to 13 months ]
    Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells

  6. Phase 2: Overall response rate [ Time Frame: up to 13 months ]
    Overall response rate per investigator assessment

  7. Phase 2: Time to response [ Time Frame: up to 13 months ]
  8. Phase 2: Duration of Response [ Time Frame: up to 13 months ]
  9. Phase 2: Progression free survival [ Time Frame: up to 13 months ]
  10. Phase 2: Overall survival [ Time Frame: up to 13 months ]


Information from the National Library of Medicine

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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 relapsed/refractory large B-cell lymphoma with at least one measurable lesion
  • At least 2 prior lines of chemotherapy including an anthracycline and an anti-CD20 monoclonal antibody
  • Prior CD19 therapy allowed with evidence of CD19 positive relapse following any prior CD19-directed therapy, including cell therapies
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Absence of donor (product)-specific anti-HLA antibodies
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma
  • Clinically significant CNS dysfunction
  • Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy
  • Prior treatment with any anti-CD52 monoclonal antibody
  • Active acute or chronic graft versus host disease (GVHD)
  • Patients unwilling to participate in an extended safety monitoring period

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, 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
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612-9416
Contact: Rachel Soto    813-745-4608    Rachel.soto@moffitt.org   
United States, Texas
SCRI Recruiting
Austin, Texas, United States, 78704
Contact: Rob Gordon    303-621-6197    Rob.Gordon@sarahcannon.com   
Sponsors and Collaborators
Allogene Therapeutics
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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: June 4, 2020
Last Verified: June 2020

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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
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