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

Summary

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

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

Conditions10

Locations40 sites

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