RECRUITING

Study of LYL314 in Aggressive Large B-Cell Lymphoma

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Conditions

Relapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaLarge B-cell LymphomaCAR T-cellCD19/20CD19CD20NHLDiffuse Large B-cell lymphomaDLBCLTransformed follicular lymphomaTFLPrimary mediastinal B-cell lymphomaPMBCLHigh-grade B-cell lymphomaHGBLfollicular lymphoma Grade 3Blarge cell follicular lymphomaAggressive B-cell NHLRefractory Aggressive B-Cell LymphomaRefractory B-Cell Non-Hodgkin LymphomaLymphoma, Non-HodgkinLymphomaLymphoma, Large B-Cell, DiffuseCyclophosphamideFludarabineLymphoma, FollicularLymphoma, B-cellImmunosuppressive AgentsImmunologic FactorsDisease AttributesImmune System DiseasesRecurrencePiNACLE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of LYL314, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

Quick Facts

Study Start:2023-05-09
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05826535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 years or older at time of informed consent
  2. 2. Willing and able to provide written informed consent
  3. 3. Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO 2017):
  4. * DLBCL
  5. * DLBCL arising from follicular lymphoma (transformed FL, tFL)
  6. * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)
  7. * High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement (HGBL)
  8. * Grade 3B follicular lymphoma/Large cell follicular lymphoma (FL3B)
  9. 4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3. Prior therapy must have included:
  10. * Anti-CD20 monoclonal antibody, and
  11. * An anthracycline containing chemotherapy regimen
  12. * Participants with tFL must have received at least one of their prior lines of therapy after transformation to DLBCL
  13. 5. Relapsed or refractory disease, defined by the following:
  14. * Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation \[ASCT\]). In participants who have only received front-line therapy, progression should be ≤ 12 months of first-line therapy (applicable for Cohort 3)
  15. * In patients who received one line of therapy, refractory disease is defined as failure to achieve at least a PR after at least 4 cycles of therapy (applicable for Cohort 3)
  16. * In patients who received two or more lines of therapy (Cohorts 1, 2, and 4), refractory disease is defined as failure to achieve a CR to last line of therapy (including CAR T and/or salvage therapy).
  17. 6. At least 1 measurable lesion (per Lugano classification). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
  18. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
  19. 8. Absolute neutrophil count (ANC) ≥ 1000/uL
  20. 9. Platelet count ≥ 50,000/uL
  21. 10. Absolute lymphocyte count (ALC) ≥ 200/uL
  1. 1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years. Participants who have received therapy for a prior malignancy within the prior 3 years, e.g., in the adjuvant setting, are not excluded
  2. 2. Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis treated at least 8 weeks prior to enrollment will not be excluded for participation if CNS disease is deemed stable at the time of study enrollment
  3. 3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
  4. 4. Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome, known vascular invasion)
  5. 5. Received the following therapies in the specified time frame prior to enrollment/leukapheresis
  6. 1. Any systemic therapy within 2 weeks
  7. 2. Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)
  8. 3. Fludarabine within 12 weeks
  9. 4. Alemtuzumab, bendamustine or antithymocyte globuline (ATG) within 6 months
  10. 5. Any T cell engager/bispecific antibody therapy such as CD20/CD3 or CD19/CD3 bispecific antibodies within 4 weeks
  11. 6. Any experimental therapy within 4 weeks or 5 half-lives (whichever is shorter)
  12. 6. Received radiation therapy within 3 weeks prior to enrollment/leukapheresis
  13. 7. Experiencing non-hematologic toxicities due to prior therapy. Exceptions include: stable and recovered to grade ≤ 1 or non-clinically significant toxicities such as (1) alopecia, (2) toxicities where Grade 2 is solely defined by participant receiving hormone replacement therapy for endocrinopathies resulting from previous checkpoint inhibitor therapy, (3) Grade 2 lymphopenia, and (4) hearing loss or Grade 2 neuropathy associated with prior treatment with taxanes or platinating agents
  14. 8. History of allogeneic stem cell or solid organ transplantation
  15. 9. Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment/leukapheresis
  16. 10. History of prior genetically modified cell therapy 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). For all other CAR T cell therapy treatments, discussion with the Sponsor's Medical Monitor is required
  17. 11. Primary immunodeficiency
  18. 12. History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. Participants who have other autoimmune condition(s) considered to be associated with underlying malignancy may be enrolled in the study after discussion with and approval of the Medical Monitor.

Contacts and Locations

Study Contact

Lyell Immunopharma Inc.
CONTACT
888-707-7917
clinicaltrials@lyell.com

Study Locations (Sites)

University of California-Irvine Medical Center
Irvine, California, 92697
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, Los Angeles (UCLA) Medical Center
Los Angeles, California, 90095
United States
Scripps Clinic
San Diego, California, 92037
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, 45267
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Intermountain Healthcare
Salt Lake City, Utah, 84143
United States
Virginia Commonwealth University-Massey Cancer Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Lyell Immunopharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-09
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2023-05-09
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • CAR T-cell
  • Non-Hodgkin Lymphoma
  • CD19/20
  • CD19
  • CD20
  • NHL
  • Diffuse Large B-cell lymphoma
  • DLBCL
  • Transformed follicular lymphoma
  • TFL
  • Primary mediastinal B-cell lymphoma
  • PMBCL
  • High-grade B-cell lymphoma
  • HGBL
  • follicular lymphoma Grade 3B
  • large cell follicular lymphoma
  • Aggressive B-cell NHL
  • Refractory Aggressive B-Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Cyclophosphamide
  • Fludarabine
  • Lymphoma, Follicular
  • Lymphoma, B-cell
  • Immunosuppressive Agents
  • Immunologic Factors
  • Disease Attributes
  • Immune System Diseases
  • Recurrence
  • PiNACLE

Additional Relevant MeSH Terms

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