A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma
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
- Cancer
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Experimental Drug |
Single infusion of CRG-022 following conditioning chemotherapy |
|
Recruiting Locations
Little Rock, Arkansas 72205
Duarte, California 91010
Los Angeles, California 90095
Stanford, California 94305
Denver, Colorado 80218
Miami, Florida 33136
Atlanta, Georgia 30342
Iowa City, Iowa 52242
Westwood, Kansas 66205
Bethesda, Maryland 20892
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Ann Arbor, Michigan 48109
Saint Louis, Missouri 63110
Buffalo, New York 14263
New York, New York 10016
Philadelphia, Pennsylvania 19107
Dallas, Texas 75390-9020
Yolanda Moore
214-645-9880
Seattle, Washington 98104
Seattle, Washington 98109
More Details
- NCT ID
- NCT05972720
- Status
- Recruiting
- Sponsor
- CARGO Therapeutics
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.