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Phase II

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:05/01/2024

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

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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.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: