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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 : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date October 14, 2021
Actual Study Start Date  ICMJE May 21, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • 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
  • 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
  • Phase 2: Overall Response Rate [ Time Frame: up to 13 months ]
    Overall response rate assessed by independent radiology review
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • 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 ]
  • 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
  • Phase 1 and 2: Pharmacokinetics of ALLO-647 [ Time Frame: up to 13 months ]
    Serum concentration levels of ALLO-647
  • 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
  • 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
  • Phase 2: Overall response rate [ Time Frame: up to 13 months ]
    Overall response rate per investigator assessment
  • Phase 2: Time to response [ Time Frame: up to 13 months ]
  • Phase 2: Duration of Response [ Time Frame: up to 13 months ]
  • Phase 2: Progression free survival [ Time Frame: up to 13 months ]
  • Phase 2: Overall survival [ Time Frame: up to 13 months ]
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-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA-2)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Large B Cell Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: ALLO-501A, ALLO-647
Interventions:
  • Genetic: ALLO-501A
  • 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2020)
120
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04416984
Other Study ID Numbers  ICMJE ALLO-501A-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
Product Manufactured in and Exported from the U.S.: 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 October 2021

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