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

Phase 1

• Conditions: arge B-Cell Lymphoma (LBCL); MedDRA version: 21.0Level: PTClassification code: 10012821Term: Diffuse large B-cell lymphoma recurrent Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-501927-25-00
• Lead Sponsor: Allogene Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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., Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1., Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening., Adequate hematological function., Adequate Renal Function., Adequate 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 HSCT within last 6 months (24 weeks) or allogeneic HSCT within last 6 months (24 weeks) prior to ALLO-647., Subjects with active systemic bacterial, fungal, or viral infection requiring systemic treatment (including positive blood cultures within 7 days before starting lymphodepletion).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified