Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Part of paid clinical trials in Irvine, California.

Sponsor
Lyell Immunopharma, Inc.
Study ID
NCT05826535
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma
  • Non-Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Rondecabtagene autoleucel (ronde-cel) — DRUG
    CAR T-cell therapy
  • Fludarabine — DRUG
    Conditioning chemotherapy
  • Cyclophosphamide — DRUG
    Conditioning chemotherapy

Study Details

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Key Dates

First listed
Apr 24, 2023
Start date
May 9, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2031

Study Design

Enrollment
270 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ph1, 3rd or later line, 3L+ have not received prior CAR T (Cohort 1)
  • Experimental: Ph1 CAR T experienced, 3L+ received at least two or more prior lines of treatment (Cohort 2)
  • Experimental: Ph1, 2L Refractory/relapse within 1 year of 1st-line therapy & no prior CAR T (Cohort 3)
  • Experimental: Ph1 (T-cell engager experienced, 3L+) received at least 2 prior lines including 1 TCE (Cohort 4)
  • Experimental: Ph1 high risk 1st line, PET-positive after 2-3 cycles chemoimmunotherapy, no prior CAR T (Cohort 5)
  • Experimental: Ph2, 3rd or later line, have not received prior CAR T (Cohort 1)
    Single dose determined during Phase 1.

Primary Outcome Measure

Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent [ Time Frame: Baseline to Month 24 ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
University of California-Irvine Medical CenterIrvineCalifornia92697-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California, Los Angeles (UCLA) Medical CenterLos AngelesCalifornia90095-
Scripps ClinicSan DiegoCalifornia92037-
Colorado Blood Cancer InstituteDenverColorado80218-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-
Augusta University Medical CenterAugustaGeorgia30912-
Indiana Blood and Marrow TransplantationIndianapolisIndiana46237-
University of IowaIowa CityIowa52242-
University of Louisville Brown Cancer CenterLouisvilleKentucky40202-
Louisiana State University Health Sciences CenterShreveportLouisiana71130-
Corewell HealthGrand RapidsMichigan49503-
University of Nebraska Medical CenterOmahaNebraska68198-
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Montefiore Medical CenterThe BronxNew York10461-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
University of Cincinnati (UC) Physicians Company, LLCCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
Lehigh Valley Topper Cancer Center InstituteAllentownPennsylvania18103-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
West Penn HospitalPittsburghPennsylvania15224-
Vanderbilt University Medical CenterNashvilleTennessee37212-
Baylor University Medical CenterDallasTexas75246-
Texas Transplant InstituteSan AntonioTexas78229-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Intermountain HealthcareSalt Lake CityUtah84143-
Virginia Oncology AssociatesNorfolkVirginia24502-
Virginia Commonwealth University-Massey Cancer CenterRichmondVirginia23298-
Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
University of California-Irvine Medical Center· Irvine, CACedars-Sinai Medical Center· Los Angeles, CAUniversity of California, Los Angeles (UCLA) Medical Center· Los Angeles, CAScripps Clinic· San Diego, CAColorado Blood Cancer Institute· Denver, COMedstar Georgetown University Hospital· Washington D.C., DC

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