Status:
RECRUITING
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Lead Sponsor:
Lyell Immunopharma, Inc.
Conditions:
Large B-cell Lymphoma
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ref...
Detailed Description
PiNACLE-H2H is a Phase 3 randomized controlled trial comparing the efficacy and safety of rondecabtagene autoleucel (ronde-cel, formerly known as LYL314) against the currently approved cluster of diff...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07188558
Start Date
January 1 2026
End Date
January 1 2032
Last Update
December 9 2025
Active Locations (39)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Honor Health
Scottsdale, Arizona, United States, 85258
3
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
4
University of Arkansas
Little Rock, Arkansas, United States, 72205