A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma

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Trial ID: NCT05972720

Purpose

This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).

Official Title

An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy

Stanford Investigator(s)

Matthew Frank

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility


Key Inclusion Criteria:

   - Aged ≥18 years

   - Relapsed or refractory large B-cell lymphoma.

   - For enrollment in cohort 1, patients must have previously received a CD19-directed CAR
   T-cell therapy

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - Adequate hematological, renal, and liver function

Key Exclusion Criteria:

   - Clinically significant concurrent medical illness

   - Active infection requiring systemic antibiotics

   - Prior allogeneic stem cell transplant or allogeneic cell therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Intervention(s):

drug: Fludarabine (Conditional therapy)

drug: Cyclophosphamide Monohydrate (Conditional therapy)

drug: CRG-022 cells (Experimental drug)

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kelly Chyan
650-625-8130

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