Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
ALPHA
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
1 other identifier
interventional
50
1 country
7
Brief Summary
The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2019
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2025
CompletedMarch 2, 2026
February 1, 2026
2.5 years
April 4, 2019
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
33 days
Study Arms (1)
ALLO-647, ALLO-501
EXPERIMENTALInterventions
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Eligibility Criteria
You may qualify if:
- Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
- Relapse or refractory disease after at least 2 lines of chemotherapy
- At least 1 measurable lesion at time of screening.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate hematological, renal, liver, pulmonary, and cardiac functions.
You may not qualify if:
- Current or history of central nervous system (CNS) lymphoma.
- Clinically significant CNS dysfunction.
- ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
- Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
- Systemic anticancer therapy within 2 weeks prior to study entry.
- On-going treatment with immunosuppressive agents.
- Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
- Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
- Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
- Patients unwilling to participate in an extended safety monitoring period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Stanford University
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
St. Davids South Austin Medical Center
Austin, Texas, 78704, United States
MD Anderson
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 39946666DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
May 6, 2019
Study Start
May 1, 2019
Primary Completion
October 23, 2021
Study Completion
January 28, 2025
Last Updated
March 2, 2026
Record last verified: 2026-02