Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
NCT ID: NCT05714345
Last Updated: 2025-12-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2023-11-01
2024-10-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Interventions
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ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Eligibility Criteria
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Inclusion Criteria
* 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
* Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
* Hypocellular bone marrow for age
18 Years
ALL
No
Sponsors
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Allogene Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Original
Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Amendment 1
Other Identifiers
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ALLO-647-201
Identifier Type: -
Identifier Source: org_study_id