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

Protocol # :
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Disease Sites
Other Hematopoietic
Non-Hodgkin's Lymphoma
Principal Investigator
Jacobson, Caron, A
Site Research Nurses
Babcock, Elise
Bright, Susan
Logan, Emma, Kristen
Maciejewski, Ashley, Taylor
Smith, Caitlin
Tichon, Jennifer

Trial Description

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).

Eligibility Requirements

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.