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Trial Title:
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
Condition:
Relapsed/Refractory Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Conditions: Keywords:
CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
ALLO-501A
ALLO-647
LBCL
Lymphoma
Large B-Cell Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ALLO-647
Description:
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Arm group label:
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Chemotherapy for lymphodepletion
Arm group label:
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Arm group label:
Lymphodepletion with fludarabine and cyclophosphamide
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Chemotherapy for lymphodepletion
Arm group label:
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Arm group label:
Lymphodepletion with fludarabine and cyclophosphamide
Intervention type:
Genetic
Intervention name:
ALLO-501A
Description:
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Arm group label:
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Arm group label:
Lymphodepletion with fludarabine and cyclophosphamide
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Louisville James Graham Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Facility:
Name:
Universitair Ziekenhuis Brussel
Address:
City:
Brussel
Zip:
1090
Country:
Belgium
Start date:
March 31, 2023
Completion date:
October 2029
Lead sponsor:
Agency:
Allogene Therapeutics
Agency class:
Industry
Source:
Allogene Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714345
