Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults with Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)
NCT ID: NCT04416984
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
160 participants
INTERVENTIONAL
2020-05-21
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALLO-501A, ALLO-647
ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Interventions
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ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
* At least 1 measurable lesion at time of enrollment
* Relapsed or refractory disease after at least 2 lines of chemotherapy
* Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)
For subjects with CLL/SLL:
* Diagnosis of CLL/SLL
* Relapsed/refractory disease
* Subjects relapsed/refractory to BTKi therapy and high-risk disease
* Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax)
* At least 1 measurable lesion at time of enrollment
For all subjects:
* Male or female subjects ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hematological, renal, and liver function
Exclusion Criteria
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
* Any other active malignancies that required systemic treatment within 3 years prior to enrollment
* Radiation therapy within 2 weeks prior to ALLO-647
* Prior irradiation to \>25% of the bone marrow
* Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).
* Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
* Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
18 Years
ALL
No
Sponsors
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Allogene Therapeutics
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital - Atlanta
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
QEII Health Sciences Centre-VG Site
Halifax, Nova Scotia, Canada
CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Countries
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References
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Locke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13.
Other Identifiers
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ALLO-501A-201
Identifier Type: -
Identifier Source: org_study_id
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