Ronde-cel versus standard CD19 CAR T‑cell therapy for relapsed or refractory large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PiNACLE-H2H is a randomized Phase 3 trial planning to enroll about 400 patients with relapsed or refractory large B‑cell lymphoma after first‑line anti‑CD20 and anthracycline chemotherapy. Participants are randomized 1:1 before leukapheresis to receive either ronde‑cel or the investigator's choice of an approved CD19 CAR T product (axi‑cel or liso‑cel), with both given as a single IV infusion following fludarabine/cyclophosphamide lymphodepletion. Ronde‑cel is an autologous, dual‑targeting CD19/CD20 CAR T product enriched for CD62L‑positive naïve and central memory T cells and uses an OR‑gated construct to activate on recognition of either antigen. Patients will be followed for three years to compare safety, response durability, and relapse patterns between the arms.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Honor Health
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles (UCLA)
  Los Angeles, California, United States Recruiting
• University of California, Irvine
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: James Dean, MD, PhD
• Email: clinicaltrials@lyell.com
• Phone: 000-000-0000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.