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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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental Drug 		Single infusion of CRG-022 following conditioning chemotherapy
  • Drug: Fludarabine (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: Cyclophosphamide Monohydrate (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: CRG-022 cells (Experimental drug)
    Investigational agent

Recruiting Locations

University of Kansas Medical Center Research Institute, Inc
Westwood, Kansas 66205
Contact:
C Stockard
913-588-0512
cstockard@kumc.edu

More Details

Status
Recruiting
Sponsor
CARGO Therapeutics

Study Contact

CargoTx Email address
(650) 499-8952
clinicaltrials@cargo-tx.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.