A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Recruiting
Phase 3
Interventional Study
Large B-cell Lymphoma
Lymphoma, B-Cell
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma Refractory/ Relapsed
Diffuse Large B Cell Lymphoma (DLBCL)
Diffuse Large B Cell Lymphoma Refractory
Diffuse Large B Cell Lymphoma Relapsed
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- Lyell Immunopharma, Inc. · Industry
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About This Trial
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 Locations
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Eligibility 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)
* Trans…
Contacts