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)
18 Years and older, Male and Female
ALLO-501A-201 (primary)
NCI-2020-04325
Summary
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.
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
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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