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

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

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 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, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : September 2024
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Proportion of subjects 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


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

Inclusion Criteria:

  • Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
  • Relapse or refractory disease after at least 2 lines of chemotherapy
  • At least 1 measurable lesion at time of screening.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma.
  • Clinically significant CNS dysfunction.
  • ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
  • Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
  • Systemic anticancer therapy within 2 weeks prior to study entry.
  • On-going treatment with immunosuppressive agents.
  • Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
  • Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
  • Patients unwilling to participate in an extended safety monitoring period
Contacts and Locations

Contacts
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Contact: Allogene 415-604-5696 clinicaltrials@allogene.com

Locations
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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    Klarissa.Jones@bannerhealth.com   
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Anna Crosetti    310-825-7412    ACrosetti@mednet.ucla.edu   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Linnea Nichols    650-724-9050    linneab@stanford.edu   
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Ben Burtness    720-754-8064    ben.burtness@sarahcannon.com   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Edelman    813-745-1040    jeffrey.edelman@moffitt.org   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Kylee Fleig    502-629-3681    kylee.fleig@nortonhealthcare.org   
United States, Texas
St. Davids South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Contact: Renee Stojanovic    512-816-6423    Renee.Stojanovic@stdavids.com   
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Swapna J Johncy    713-792-8251    sjjohncy@mdanderson.org   
Contact: Sherry Adkins    713-745-3035    sadkins@mdanderson.org   
Sponsors and Collaborators
Allogene Therapeutics
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021)
  • Proportion of subjects 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
  • 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
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original 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 ]
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 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, 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
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
  • 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 11, 2021) 		74
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2019) 		24
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
  • Relapse or refractory disease after at least 2 lines of chemotherapy
  • At least 1 measurable lesion at time of screening.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma.
  • Clinically significant CNS dysfunction.
  • ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
  • Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
  • Systemic anticancer therapy within 2 weeks prior to study entry.
  • On-going treatment with immunosuppressive agents.
  • Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
  • Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
  • 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 2021

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

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