A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
About this study
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
- Condition
- Large B-cell Lymphoma, Lymphoma, B-Cell, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Diffuse Large B Cell Lymphoma (DLBCL), Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B Cell Lymphoma Relapsed
- Tested
- rondecabtagene autoleucel, axicabtagene ciloleucel, lisocabtagene maraleucel
- Sponsor
- Lyell Immunopharma, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 14
- Minimum age: 18 years
- Study condition: Large B-cell Lymphoma, Lymphoma, B-Cell, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Diffuse Large B Cell Lymphoma (DLBCL), Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B Cell Lymphoma Relapsed
- CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
- Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
- Diffuse large B-cell lymphoma (DLBCL)
- Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
- DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
- High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B)
- Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
- Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
Exclusion 7
- Patients ineligible to receive CD19 CAR T-cell therapy
- Primary CNS lymphoma
- Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)
- Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
- Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Where
36 sites, 36 recruiting
Northside Hospital
Atlanta, Georgia, United States
University of Colorado
Aurora, Colorado, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of Chicago
Chicago, Illinois, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
and 30 more sites on ClinicalTrials.gov
Contact
-
David Shook, MD
000-000-0000 clinicaltrials@lyell.com
-
Mary Lessig, MS
000-000-0000 clinicaltrials@lyell.com
Potential match only. Final eligibility is determined by the study team.