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

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. Identifier: NCT03939026
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

Primary Outcome Measures :
  1. Proportion of patients 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

Secondary Outcome Measures :
  1. Incidence and severity of adverse events with ALLO-501 and ALLO-647 in combination with fludarabine/cyclophosphamide [ Time Frame: Up to 9 months ]
  2. Cellular kinetics of ALLO-501 [ Time Frame: Up to 9 months ]
    Levels of Anti-CD19 CAR T Cells in Blood

  3. Pharmacokinetics of ALLO-647 [ Time Frame: Up to 9 months ]
    Serum concentration levels of ALLO-647

  4. Incidence of immunogenicity against ALLO-501 and ALLO-647 [ Time Frame: Up to 9 months ]
  5. Immune monitoring after lymphodepletion regimen [ Time Frame: Up to 9 months ]
    Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells

  6. Overall Response Rate [ Time Frame: Up to 9 months ]
  7. Duration of response [ Time Frame: Up to 9 months ]
  8. Progression-free survival [ Time Frame: Up to 9 months ]
  9. Time to Response [ Time Frame: Up to 9 months ]
  10. Overall survival [ Time Frame: Up to 9 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven relapsed or refractory aggressive large B-cell lymphoma or follicular lymphoma with at least one measurable lesion
  • At least 2 prior lines of therapies including an anthracycline and an anti-CD20 monoclonal antibody for large B-cell lymphoma and an anti-CD20 monoclonal antibody for follicular lymphoma
  • 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 or any anti-CD19 therapies that include the 4G7 scFv clone
  • 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 identifier (NCT number): NCT03939026

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Contact: Allogene 415-604-5696

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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Klarissa Jones, RN, BSN    602-747-3647   
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Anna Crosetti    310-825-7412   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Juliana Craig    650-736-0912   
United States, Colorado
Sarah Cannon/Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Kristine Brovsky    844-482-4812   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Edelman    813-745-1040   
United States, Texas
Sarah Cannon/St. Davids South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Contact: Robert Gordon    303-621-6197   
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Swapna J Johncy    713-792-8251   
Contact: Sherry Adkins    713-745-3035   
Sponsors and Collaborators
Allogene Therapeutics
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Responsible Party: Allogene Therapeutics Identifier: NCT03939026    
Other Study ID Numbers: ALLO-501-201
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists