Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)

About

Brief Summary

The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I/II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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
ECOG performance status 0 or 1
Absence of donor (product)-specific anti-HLA antibodies (DSA)
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
Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647
Subjects with active systemic bacterial, fungal, or viral infection requiring systemic treatment (including positive blood cultures within 7 days before starting lymphodepletion)

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