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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allogene Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
