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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)

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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

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • 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
  • 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
  • Phase 2: Overall Response Rate [ Time Frame: Up to 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • 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 ]
  • Phase 1 and 2: Cellular kinetics of ALLO-501 [ Time Frame: Up to 9 months ]
    Levels of Anti-CD19 CAR T Cells in Blood
  • Phase 1 and 2: Pharmacokinetics of ALLO-647 [ Time Frame: Up to 9 months ]
    Serum concentration levels of ALLO-647
  • Phase 1 and 2: Incidence of immunogenicity against ALLO-501 and ALLO-647 [ Time Frame: Up to 9 months ]
  • 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
  • Phase 1: Overall Response Rate [ Time Frame: Up to 9 months ]
  • Phase 1 and 2: Duration of response [ Time Frame: Up to 9 months ]
  • Phase 1 and 2: Progression-free survival [ Time Frame: Up to 9 months ]
  • Phase 1 and 2: Time to Response [ Time Frame: Up to 9 months ]
  • Phase 1 and 2: Overall survival [ Time Frame: Up to 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed/Refractory Large B Cell Lymphoma
  • Relapsed/Refractory Follicular Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: ALLO-647, ALLO-501
Interventions:
  • Genetic: ALLO-501
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allogene 415-604-5696 clinicaltrials@allogene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939026
Other Study ID Numbers  ICMJE ALLO-501-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allogene Therapeutics
Study Sponsor  ICMJE Allogene Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allogene Therapeutics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP