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

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

Phase 3 Interventional Lyell Immunopharma, Inc. · NCT07188558

This test sees if ronde-cel, a CAR T therapy that targets both CD19 and CD20, works better than currently used CD19 CAR T therapies for adults whose large B‑cell lymphoma returned or did not respond after first‑line treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorLyell Immunopharma, Inc. Industry-sponsored
Drugs / interventionsCAR T, CART, chimeric antigen receptor, chemotherapy, cyclophosphamide, fludarabine
Locations39 sites (Gilbert, Arizona and 38 other locations)
Trial IDNCT07188558 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically confirmed large B‑cell lymphoma that relapsed or is refractory after anti‑CD20 plus anthracycline first‑line chemo, who are CAR T–naïve, have ECOG 0–1 and measurable PET‑positive disease, are eligible for this trial.

Not a fit: Patients previously treated with any CAR T‑cell therapy, those ineligible for leukapheresis or lymphodepletion, or those with poor performance status or excluded lymphoma subtypes are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, ronde‑cel could produce longer, more durable remissions and fewer relapses by targeting both CD19 and CD20 and improving CAR T‑cell persistence.

How similar studies have performed: Approved CD19 CAR T therapies such as axi‑cel and liso‑cel have shown substantial activity in this setting, while dual CD19/CD20 CAR approaches are newer and supported mainly by early‑phase data suggesting potential to reduce antigen‑loss relapse.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gilbert, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Large B-cell LymphomaLymphoma, B-CellRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaNon-Hodgkin Lymphoma Refractory/ RelapsedDiffuse Large B Cell LymphomaDiffuse Large B Cell Lymphoma Refractory
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.