Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

NCT05826535
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
270
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Lead sponsor
Lyell Immunopharma, Inc.
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Start date
2023-05-09
clinicaltrials.gov
Number of sites
35
clinicaltrials.gov

Summary
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.
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Short title
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
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Official title
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2031-06-30
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First posted
2023-04-24
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Registry last updated
2026-08-25
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Primary completion date
2028-12-31
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Start date
2023-05-09
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Participants
270
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Participant count basis
Estimated
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Planned participants
270
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Protocol amendments
10
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Number of sites
35
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Lyell Immunopharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05826535
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ClinicalTrials.gov ID
NCT05826535
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent

    Timeframe: Baseline to Month 24

    Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs)

  2. Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR)

    Timeframe: Baseline to Month 24

    ORR based on Independent Review Committee (IRC) assessment per Lugano criteria

  1. Phase 1: Evaluate the efficacy of ronde-cel

    Timeframe: Baseline to Month 24

    Overall response rate (ORR), Complete response rate (CRR), duration of response (DOR), duration of complete response (DOCR), progression free survival (PFS) based on Investigator assessment until a pivotal trial (Phase 2) portion is initiated at which time all scans will be reviewed by an IRC assessment (Cohort 1) per Lugano criteria

  2. Phase 1: Evaluate the feasibility of treatment with ronde-cel

    Timeframe: Baseline to Month 24

    Proportion of enrolled participants who receive the target dose of ronde-cel

  3. Phase 1: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent

    Timeframe: Baseline to Month 24

    Maximum concentration (Cmax), area under the curve from time 0 to Day 28 (AUC0-28) and persistence of ronde-cel

  4. Phase 2: Estimate the efficacy of ronde-cel

    Timeframe: Baseline to Month 24

    ORR based on Investigator assessment per Lugano criteria

  5. Phase 2: Estimate the efficacy of ronde-cel

    Timeframe: Baseline to Month 24

    DOR based on IRC assessment and investigator assessment per Lugano criteria

  6. Phase 2: Estimate the efficacy of ronde-cel

    Timeframe: Baseline to Month 24

    Time to response (TTR) based on IRC assessment and investigator assessment per Lugano criteria

  7. Phase 2: Estimate the efficacy of ronde-cel

    Timeframe: Baseline to Month 24

    PFS based on IRC assessment and investigator assessment per Lugano criteria

  8. Phase 2: Estimate the efficacy of ronde-cel

    Timeframe: Baseline to Month 72

    Overall Survival (OS)

  9. Phase 2: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent

    Timeframe: Baseline to Month 24

    Incidence and severity of TEAEs

  10. Phase 2: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent

    Timeframe: Baseline to Month 24

    Maximum concentration (Cmax), area under the curve from time 0 to Day 28 (AUC0-28) and persistence of ronde-cel

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Age 18 years or older
  2. Willing and able to provide written informed consent
  3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
  4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
  5. Relapsed or refractory disease.
  6. At least 1 measurable lesion (per Lugano classification)
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
  8. Absolute neutrophil count (ANC) ≥ 1000/µL
  9. Platelet count ≥ 50,000/µL
  10. Absolute lymphocyte count (ALC) ≥ 200/µL

Other protocol-defined criteria apply.

  1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
  2. Active central nervous system involvement
  3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
  4. Ongoing or impending oncologic emergency
  5. Recent systemic anti-cancer therapy or radiation
  6. Ongoing non-hematologic toxicities due to prior therapy
  7. History of allogeneic stem cell or solid organ transplantation
  8. Autologous stem cell transplantation within 6 weeks
  9. History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
  10. Primary immunodeficiency
  11. History of autoimmune disease resulting in end organ injury or requiring recent therapy

Other protocol-defined criteria apply.

Sources for eligibility
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  • University of California-Irvine Medical CenterIrvine, United StatesRecruiting
  • Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting
  • University of California, Los Angeles (UCLA) Medical CenterLos Angeles, United StatesRecruiting
  • Scripps ClinicSan Diego, United StatesRecruiting
  • Colorado Blood Cancer InstituteDenver, United StatesRecruiting
  • Medstar Georgetown University HospitalWashington D.C., United StatesRecruiting
  • Augusta University Medical CenterAugusta, United StatesRecruiting
  • Indiana Blood and Marrow TransplantationIndianapolis, United StatesRecruiting
  • University of IowaIowa City, United StatesRecruiting
  • University of Louisville Brown Cancer CenterLouisville, United StatesRecruiting
  • Louisiana State University Health Sciences CenterShreveport, United StatesRecruiting
  • Corewell HealthGrand Rapids, United StatesRecruiting
  • University of Nebraska Medical CenterOmaha, United StatesRecruiting
  • John Theurer Cancer Center Hackensack University Medical CenterHackensack, United StatesRecruiting
  • University of New Mexico Comprehensive Cancer CenterAlbuquerque, United StatesRecruiting
  • Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Montefiore Medical CenterThe Bronx, United StatesRecruiting
  • Atrium Health Wake Forest BaptistWinston-Salem, United StatesRecruiting
  • University of Cincinnati (UC) Physicians Company, LLCCincinnati, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • Lehigh Valley Topper Cancer Center InstituteAllentown, United StatesRecruiting
  • Thomas Jefferson UniversityPhiladelphia, United StatesRecruiting
  • West Penn HospitalPittsburgh, United StatesRecruiting
  • Vanderbilt University Medical CenterNashville, United StatesRecruiting

And 10 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (6)

Targets (2)