Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing rondecabtagene autoleucel for Large B-cell Lymphoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07188558 · Lyell Immunopharma, Inc. · enrollment listed as 400

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are rondecabtagene autoleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. The registry lists allocation as randomized. 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.

They plan to enroll about 400 people at 44 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: rondecabtagene autoleucel, axicabtagene ciloleucel, lisocabtagene maraleucel

Primary outcome (registry wording): Event free survival

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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)

Public study contact (from the registry)

James Dean, MD, PhD

000-000-0000

clinicaltrials@lyell.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

44 listed

+ 3 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07188558 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07188558?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07188558?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary