Back to resultsEvaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (EXPAND)
Primary Purpose
Relapsed/Refractory Large B Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALLO-647
Fludarabine
Cyclophosphamide
ALLO-501A
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Large B Cell Lymphoma focused on measuring CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501A, ALLO-647, LBCL, Lymphoma, Large B-Cell Lymphoma
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
Sites / Locations
- Indiana Blood & Marrow TransplantationRecruiting
- Atrium Health Wake Forest Baptist Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Lymphodepletion with fludarabine and cyclophosphamide
Arm Description
ALLO-501A CAR T cells infused following lymphodepletion
ALLO-501A CAR T cells infused following lymphodepletion
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms
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
To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms
To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms
To characterize the efficacy of ALLO-647 as measured by response rate per investigator review
To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms
To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS)
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
To characterize the serum concentration of ALLO-647 as measured by microgram per microliter
To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number
To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter
To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A
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
To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05714345
Brief Title
Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Acronym
EXPAND
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allogene Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Large B Cell Lymphoma
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501A, ALLO-647, LBCL, Lymphoma, Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
Arm Type
Experimental
Arm Description
ALLO-501A CAR T cells infused following lymphodepletion
Arm Title
Lymphodepletion with fludarabine and cyclophosphamide
Arm Type
Experimental
Arm Description
ALLO-501A CAR T cells infused following lymphodepletion
Intervention Type
Biological
Intervention Name(s)
ALLO-647
Intervention Description
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Genetic
Intervention Name(s)
ALLO-501A
Intervention Description
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
To characterize the efficacy of ALLO-647 as measured by response rate per investigator review
Time Frame
Up to 60 months
Title
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
Title
To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS)
Time Frame
Up to 60 months
Title
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
Title
To characterize the serum concentration of ALLO-647 as measured by microgram per microliter
Time Frame
Up to 10 days
Title
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
Title
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
Title
To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A
Time Frame
Up to 9 months
Title
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
Title
To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion
Time Frame
Up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allogene Therapeutics
Phone
415-604-5696
Email
clinicaltrials@allogene.com
Facility Information:
Facility Name
Indiana Blood & Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Coleman
Phone
317-528-7298
Email
melanie.coleman@franciscanalliance.org
Facility Name
Atrium Health Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakhee Vaidya, MD
Phone
336-716-2774
Email
ravaidya@wakehealth.edu
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
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