Chronic Lymphocytic Leukemia Clinical Trial
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)
Summary
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and leukemia-cll/" >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.
Eligibility Criteria
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
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There are 38 Locations for this study
New Haven Connecticut, 06510, United States
Miami Florida, 33136, United States
New York New York, 10065, United States
Portland Oregon, 97213, United States
Pittsburgh Pennsylvania, 15212, United States
Sioux Falls South Dakota, 57117, United States
Milwaukee Wisconsin, 53226, United States
Woolloongabba Queensland, 4102, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3004, Australia
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 2, Canada
Québec , G1J 1, Canada
Bologna , 40138, Italy
Milan , 20132, Italy
Torino , 10126, Italy
Barcelona , 08035, Spain
Donostia-San Sebastian , 20014, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Salamanca , 37007, Spain
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