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
- Study HIC#:2000035657
- Last Updated:04/12/2024
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).
Contact Us
For more information about this study, including how to volunteer, contact:
Jialing Zhang
- Phone Number: 1-203-737-8884
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Trial Purpose and Description
CRG-022 is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of CRG-022 in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of CRG-022.
Eligibility Criteria
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.
