KITE-197 treatment for relapsed or refractory large B-cell lymphoma
A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
This study is testing a new treatment called KITE-197 for people with relapsed or refractory large B-cell lymphoma to see if it is safe and effective in helping them achieve remission.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gilead Sciences Industry-sponsored |
| Drugs / interventions | tafasitamab, loncastuximab, chemotherapy |
| Locations | 12 sites (Miami, Florida and 11 other locations) |
| Trial ID | NCT06079164 on ClinicalTrials.gov |
What this trial studies
This clinical trial consists of two phases aimed at evaluating the safety and effectiveness of KITE-197 in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). Phase 1a focuses on determining the safety, tolerability, and appropriate dosing of KITE-197, while Phase 1b assesses the efficacy of the recommended dose by measuring the complete remission rate. Participants will be monitored for approximately 24 months post-infusion, followed by long-term follow-up for up to 15 years. The study involves the administration of KITE-197 along with Cyclophosphamide and Fludarabine.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with relapsed or refractory large B-cell lymphoma who have at least one measurable lesion and adequate organ and bone marrow function.
Not a fit: Patients with a history of certain malignancies, prior stem cell transplants, or specific previous therapies targeting CD19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory large B-cell lymphoma.
How similar studies have performed: Other studies targeting similar conditions with innovative therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Relapsed or Refractory Large B-cell Lymphoma * At least 1 measurable lesion * Adequate organ and bone marrow function Key Exclusion Criteria: * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 2 years * History of Richter's transformation of chronic leukemic lymphoma * History of allogenic stem cell transplant (SCT) * Autologous SCT within 6 weeks of planned KITE-197 infusion * Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. Individuals who meet these criteria may be eligible * Prior treatment with bendamustine within 6 months of enrollment * Prior CAR therapy or other genetically modified cell therapy * Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management * History of HIV infection or acute or chronic active hepatitis B or C infection * History or presence of a clinically significant central nervous system (CNS) disorder Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion. * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment * Presence of primary immunodeficiency * History of autoimmune disease (eg, 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 * History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted * Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Miami, Florida and 11 other locations
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States (Recruiting)
- St. David's South Austin Medical Center — Austin, Texas, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — South Brisbane, Queensland, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Cross Cancer Institute — Edmonton, Canada (Recruiting)
- QEII Health Sciences Centre — Halifax, Canada (Recruiting)
- Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont — Montréal, Canada (Active_not_recruiting)
- Jewish General Hospital — Montréal, Canada (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: medinfo@kitepharma.com
- Phone: 844-454-5483(1-844-454-KITE)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.