Study on JNJ-90014496 for Treating B-Cell Non-Hodgkin Lymphoma
Sponsor: Janssen Research & Development, LLC
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| University of Iowa Hospital and Clinics | 52242 | Iowa City | Iowa |
| University of Kentucky Medical Center | 40536 | Lexington | Kentucky |
| Rutgers Cancer Institute of New Jersey | 08854 | Piscataway | New Jersey |
| Levine Cancer Institute | 28001 | Charlotte | North Carolina |
| University Hospitals Cleveland Medical Center | 44106 | Cleveland | Ohio |
| University of Pittsburgh Medical Center | 15232 | Pittsburgh | Pennsylvania |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| St. David's South Austin Medical Center | 78704 | Austin | Texas |
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