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Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (EXPAND)

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ClinicalTrials.gov Identifier: NCT05714345
Recruitment Status : Recruiting
First Posted : February 6, 2023
Last Update Posted : December 14, 2023
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

Study Description
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Brief Summary:
The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Large B Cell Lymphoma Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide Genetic: ALLO-501A Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
 Biological: ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Drug: Fludarabine
Chemotherapy for lymphodepletion

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Experimental: Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
 Drug: Fludarabine
Chemotherapy for lymphodepletion

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19


Outcome Measures
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Primary Outcome Measures :
  1. To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by IRC in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma) [ Time Frame: Up to 60 months ]

Secondary Outcome Measures :
  1. To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
  2. To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by IRC in subjects with R/R LBCL [ Time Frame: Up to 60 months ]
  3. To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
  4. To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
  5. To characterize the efficacy of ALLO-647 as measured by response rate per investigator review [ Time Frame: Up to 60 months ]
  6. To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms [ Time Frame: Up to 60 months ]
  7. To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS) [ Time Frame: Up to 60 months ]
  8. To characterize lymphodepletion with and without ALLO-647 as measured by absolute lymphocyte count/microliter; T cell counts/microliter; B cell counts/microliter, NK cell counts/microliter [ Time Frame: Up to 9 months ]
  9. To characterize the serum concentration of ALLO-647 as measured by microgram per microliter [ Time Frame: Up to 10 days ]
  10. To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number [ Time Frame: Up to 9 months ]
  11. To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter [ Time Frame: Up to 9 months ]
  12. To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A [ Time Frame: Up to 9 months ]
  13. To evaluate the incidence of treatment-emergent adverse events of ALLO-647 by comparing ALLO-647, fludarabine, and cyclophosphamide (FCA) lymphodepletion with fludarabine and cyclophosphamide (FC) lymphodepletion [ Time Frame: Up to 60 months ]
  14. To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion [ Time Frame: Up to 60 months ]

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:

  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • ECOG performance status 0 or 1
  • Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Active central nervous system involvement by malignancy
  • Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
  • Hypocellular bone marrow for age
Contacts and Locations
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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): NCT05714345


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

Locations
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United States, Florida
University of Florida Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Erin Dean    352-273-7832    erin.dean@medicine.ufl.edu   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller    404-727-4995    ewaller@emory.edu   
United States, Illinois
University of Illinois Hospital & Health Sciences System Recruiting
Chicago, Illinois, United States, 60612
Contact: Carlos Galvez    312-996-8866    cgalve3@uic.edu   
United States, Indiana
Indiana Blood & Marrow Transplantation Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Melanie Coleman    317-528-7298    melanie.coleman@franciscanalliance.org   
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Hassaan Yasin, MD    502-562-3919    cancertrials@louisville.edu   
United States, New Jersey
Astera Cancer Care - East Brunswick Recruiting
New Brunswick, New Jersey, United States, 08816
Contact: Edward Licitra    732-390-7750    Stephanie.Ortiz@asterahealthcare.org   
United States, North Carolina
Atrium Health Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rakhee Vaidya, MD    336-716-2774    ravaidya@wakehealth.edu   
United States, Ohio
University of Cincinnati Health Barett Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Tahir Latif    513-584-2118    latiftr@ucmail.uc.edu   
United States, South Carolina
Prisma Health Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Suzanne Fanning    864-522-2066    suzanne.fanning@prismahealth.org   
Austria
Salzburg Cancer Research Institute Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil    4366244822879    r.greil@salk.at   
Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussel, Belgium, 1090
Contact: Ann De Becker    3224776211    ann.debecker@uzbrussel.be   
Sponsors and Collaborators
Allogene Therapeutics
More Information
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Responsible Party: Allogene Therapeutics
ClinicalTrials.gov Identifier: NCT05714345    
Other Study ID Numbers: ALLO-647-201
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: December 14, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allogene Therapeutics:
CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
 ALLO-501A
ALLO-647
LBCL
Lymphoma
Large B-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
 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