Study on JNJ-90014496 for Treating B-Cell Non-Hodgkin Lymphoma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT05421663

This clinical trial is testing a new CAR T-cell therapy, JNJ-90014496, which targets specific proteins on cancer cells, to treat adults with certain types of B-Cell Non-Hodgkin Lymphoma that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study is exploring a new treatment called JNJ-90014496, a CAR T-cell therapy that targets two proteins, CD19 and CD20, found on cancer cells. This treatment is for adults with B-Cell Non-Hodgkin Lymphoma (B-NHL) that has come back or not responded to other treatments, or for those with high-risk diffuse large B-cell lymphoma (DLBCL) who are receiving their first treatment. The study aims to see if this new therapy can help control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Cancer must be confirmed to have CD19 and/or CD20 proteins.
  • For Phase 1b:
    • Relapsed or refractory aggressive large B-cell NHL or follicular lymphoma (FL) Grade 3b: Must have had at least 2 previous treatments or 1 treatment if not eligible for high-dose chemotherapy and stem cell transplant.
    • Relapsed or refractory FL Grade 1-3a and marginal zone lymphoma: Must have had at least 2 previous treatments and prior exposure to an anti-CD20 antibody.
    • Frontline high-risk DLBCL: Must have DLBCL or high-grade B-cell lymphoma with remaining cancer after 2 or 3 cycles of initial chemoimmunotherapy.
  • For Phase 2:
    • Must have large B-cell lymphoma, follicular large B-cell lymphoma, or transformed indolent lymphoma.
    • Must have had at least 2 previous treatments, including anthracycline chemotherapy and an anti-CD20 antibody.
    • Cancer must have returned or not responded to the most recent treatment.
  • Must have measurable disease.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • History of serious blood clots or lung clots within six months.
  • History of stroke, severe heart problems, or heart rhythm issues within six months.
  • History of seizures, dementia, or other serious brain disorders.
  • History of optic neuritis or other immune-related brain diseases.
  • Active liver or bile duct disease, except for certain conditions like Gilbert's syndrome.
  • Active infections requiring treatment.
  • Certain types of lymphoma or other specific conditions.
  • Previous solid organ or allogeneic stem cell transplant.
  • Recent autologous stem cell transplant within 12 weeks.
  • For those previously treated with CAR-T: No CAR-T therapy within 12 weeks.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia
Colorado Blood Cancer Institute80218DenverColorado
University of Iowa Hospital and Clinics52242Iowa CityIowa
University of Kentucky Medical Center40536LexingtonKentucky
Rutgers Cancer Institute of New Jersey08854PiscatawayNew Jersey
Levine Cancer Institute28001CharlotteNorth Carolina
University Hospitals Cleveland Medical Center44106ClevelandOhio
University of Pittsburgh Medical Center15232PittsburghPennsylvania
Sarah Cannon Research Institute37203NashvilleTennessee
St. David's South Austin Medical Center78704AustinTexas

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