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)


I'm Interested

Trial ID: NCT04416984


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
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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

   - 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


genetic: ALLO-501A

biological: ALLO-647

drug: Fludarabine

drug: Cyclophosphamide


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Bjornlund Nichols

New Trial Alerts