A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Lyell Immunopharma, Inc.
Study ID
NCT07188558
Phase
PHASE3
Status
Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B Cell Lymphoma Relapsed
  • Large B-cell Lymphoma
  • Lymphoma, B-Cell
  • Non-Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma Refractory/ Relapsed
  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rondecabtagene autoleucel — BIOLOGICAL
    An autologous, dual-targeting CD19/20 CAR T-cell candidate.
  • axicabtagene ciloleucel — BIOLOGICAL
    An autologous CD19 CAR T-cell therapy
  • lisocabtagene maraleucel — BIOLOGICAL
    An autologous CD19 CAR T-cell therapy

Study Details

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.

Key Dates

Start date
Jan 12, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Jan 31, 2032

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rondecabtagene autoleucel
  • Active Comparator: Investigator's Choice CD19
    axicabtagene ciloleucel, lisocabtagene maraleucel

Primary Outcome Measure

Event free survival [ Time Frame: 36 months ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Honor HealthScottsdaleArizona85258-
Mayo Clinic ArizonaScottsdaleArizona85259-
University of ArkansasLittle RockArkansas72205-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095-
University of California, IrvineOrangeCalifornia92868-
University of ColoradoAuroraColorado80045-
Colorado Blood Cancer InstituteDenverColorado80218-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Mayo Clinic FloridaJacksonvilleFlorida32224-
AdventHealthOrlandoFlorida32804-
Moffitt Cancer CenterTampaFlorida33612-
Northside HospitalAtlantaGeorgia30342-
NorthwesternChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
University of IowaIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas66205-
University of KentuckyLexingtonKentucky40536-
University of Louisville HealthLouisvilleKentucky40202-
Corewell HealthGrand RapidsMichigan49503-
Mayo Clinic RochesterRochesterMinnesota55905-
University of Nebraska Medical Center (UNMC)OmahaNebraska68105-
HackensackHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Duke Cancer InstituteDurhamNorth Carolina27705-
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Oncology Hematology Care Clinical TrialsCincinnatiOhio45242-
University of CincinnatiCincinnatiOhio45267-
Cleveland Clinical Taussig Cancer CenterClevelandOhio44195-
Allegheny Health NetworkPittsburghPennsylvania15212-
SCRI Oncology PartnersNashvilleTennessee37203-
St. David's South Austin Medical CenterAustinTexas78704-
University of Texas Southwestern Medical CenterFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Transplant InstituteSan AntonioTexas78229-
Intermountain HealthcareSalt Lake CityUtah84143-
Virginia Oncology AssociatesNorfolkVirginia23502-

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