Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ALPHA Allogene | United States
Previous Study | Return to List | Next Study

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.
ClinicalTrials.gov Identifier: NCT03939026
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
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 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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-501, an Anti-CD19 Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Estimated Study Start Date : May 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. Phase 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. Phase 1: 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

  3. Phase 2: Overall Response Rate [ Time Frame: Up to 9 months ]

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

  3. Phase 1 and 2: Pharmacokinetics of ALLO-647 [ Time Frame: Up to 9 months ]
    Serum concentration levels of ALLO-647

  4. Phase 1 and 2: Incidence of immunogenicity against ALLO-501 and ALLO-647 [ Time Frame: Up to 9 months ]
  5. Phase 1 and 2: 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. Phase 1: Overall Response Rate [ Time Frame: Up to 9 months ]
  7. Phase 1 and 2: Duration of response [ Time Frame: Up to 9 months ]
  8. Phase 1 and 2: Progression-free survival [ Time Frame: Up to 9 months ]
  9. Phase 1 and 2: Time to Response [ Time Frame: Up to 9 months ]
  10. Phase 1 and 2: 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.


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

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
  • 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 or history of thyroid disorder
  • Prior treatment with any anti-CD52 or anti-CD19 therapy, gene therapy, genetically modified cell therapy, or adoptive T-cell therapy
  • Active acute or chronic graft versus host disease (GVHD)
  • History of HIV infection or acute or chronic active hepatitis B or C infection
  • 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): NCT03939026


Contacts
Layout table for location contacts
Contact: Allogene 415-604-5696 clinicaltrials@allogene.com

Locations
Layout table for location information
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Klarissa Jones, RN, BSN    602-747-3647    Klarissa.Jones@bannerhealth.com   
United States, Colorado
Sarah Cannon/Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Kristine Brovsky    844-482-4812    Kristine.Brovsky@sarahcannon.com   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Edelman    813-745-1040    jeffrey.edelman@moffitt.org   
Sponsors and Collaborators
Allogene Therapeutics

Layout table for additonal information
Responsible Party: Allogene Therapeutics
ClinicalTrials.gov Identifier: NCT03939026     History of Changes
Other Study ID Numbers: ALLO-501-201
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Allopurinol
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
Antimetabolites
Enzyme Inhibitors
Gout Suppressants
Free Radical Scavengers
Antioxidants
Protective Agents