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)
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)
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.
Not Available
Phase II
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
ALLO-647,
Cema-cel,
Cyclophosphamide,
Fludarabine
Jallouk, Andrew
International
Vanderbilt University
02-19-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
For subjects with LBCL:
For subjects with LBCL:
Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
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
At least 1 measurable lesion at time of enrollment
Relapsed or refractory disease after at least 2 lines of chemotherapy
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)
Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)
For subjects with CLL/SLL:
For subjects with CLL/SLL:
Diagnosis of CLL/SLL
Diagnosis of CLL/SLL
Relapsed/refractory disease
Relapsed/refractory disease
Subjects relapsed/refractory to BTKi therapy and high-risk 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)
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
At least 1 measurable lesion at time of enrollment
For all subjects:
For all subjects:
Male or female subjects 18 years of age
Male or female subjects 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Adequate hematological, renal, and liver function
Adequate hematological, renal, and liver function
Exclusion Criteria:
Active central nervous system (CNS) involvement by malignancy
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
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
Any other active malignancies that required systemic treatment within 3 years prior to enrollment
Radiation therapy within 2 weeks prior to ALLO-647
Radiation therapy within 2 weeks prior to ALLO-647
Prior irradiation to >25% of the bone marrow
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).
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)
Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
For subjects with LBCL:
For subjects with LBCL:
Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
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
At least 1 measurable lesion at time of enrollment
Relapsed or refractory disease after at least 2 lines of chemotherapy
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)
Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)
For subjects with CLL/SLL:
For subjects with CLL/SLL:
Diagnosis of CLL/SLL
Diagnosis of CLL/SLL
Relapsed/refractory disease
Relapsed/refractory disease
Subjects relapsed/refractory to BTKi therapy and high-risk 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)
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
At least 1 measurable lesion at time of enrollment
For all subjects:
For all subjects:
Male or female subjects 18 years of age
Male or female subjects 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Adequate hematological, renal, and liver function
Adequate hematological, renal, and liver function
Exclusion Criteria:
Active central nervous system (CNS) involvement by malignancy
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
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
Any other active malignancies that required systemic treatment within 3 years prior to enrollment
Radiation therapy within 2 weeks prior to ALLO-647
Radiation therapy within 2 weeks prior to ALLO-647
Prior irradiation to >25% of the bone marrow
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).
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)
Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
