A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
PiNACLE-H2H
A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
1 other identifier
interventional
400
1 country
39
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 refractory large B-cell lymphoma in the second-line setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Longer than P75 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2032
March 4, 2026
March 1, 2026
3.9 years
September 16, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event free survival
The time interval from treatment initiation until the occurrence of a specific event of interest.
36 months
Secondary Outcomes (5)
Overall Response Rate
36 months
Complete Response Rate
36 months
Progression Free Survial
36 months
Overall Survival
6 years
Incidence and severity adverse events
36 months
Study Arms (2)
Rondecabtagene autoleucel
EXPERIMENTALInvestigator's Choice CD19
ACTIVE COMPARATORaxicabtagene ciloleucel, lisocabtagene maraleucel
Interventions
An autologous, dual-targeting CD19/20 CAR T-cell candidate.
An autologous CD19 CAR T-cell therapy
An autologous CD19 CAR T-cell therapy
Eligibility Criteria
You may qualify if:
- CAR T cell naĂ¯ve 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Honor Health
Scottsdale, Arizona, 85258, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of Arkansas
Little Rock, Arkansas, 72205, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095, United States
University of California, Irvine
Orange, California, 92868, United States
University of Colorado
Aurora, Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
AdventHealth
Orlando, Florida, 32804, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Louisville Health
Louisville, Kentucky, 40202, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, 68105, United States
Hackensack
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Duke Cancer Institute
Durham, North Carolina, 27705, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45242, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinical Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
University of Texas Southwestern Medical Center
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Intermountain Healthcare
Salt Lake City, Utah, 84143, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2025
First Posted
September 23, 2025
Study Start
January 12, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
January 1, 2032
Last Updated
March 4, 2026
Record last verified: 2026-03