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A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

RecruitingPhase 3

Sponsor: Lyell Immunopharma, Inc.

Conditions: Large B-cell Lymphoma, Lymphoma, B-Cell, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma

Interventions: rondecabtagene autoleucel, axicabtagene ciloleucel, lisocabtagene maraleucel

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
2. 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)
3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function

Key Exclusion Criteria:

1. Patients ineligible to receive CD19 CAR T-cell therapy
2. Primary CNS lymphoma
3. 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)
4. 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
5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations (36)

Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
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