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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)
Recruiting
I'm InterestedTrial ID: NCT04416984
Purpose
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult
subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety,
efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell
lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen
comprising fludarabine, cyclophosphamide, and ALLO-647.
Official Title
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Stanford Investigator(s)
David Miklos
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
For subjects with LBCL:
- 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:
- Active central nervous system (CNS) involvement by malignancy
- 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
Intervention(s):
genetic: ALLO-501A
biological: ALLO-647
drug: Fludarabine
drug: Cyclophosphamide
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Linnea Bjornlund Nichols
650-724-9050