Your session is about to expire
← Back to Search
CAR T-cell Therapy
KITE-197 for Large B-cell Lymphoma
Phase 1
Recruiting
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or Refractory Large B-cell Lymphoma
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called KITE-197 for patients whose large B-cell lymphoma has returned or didn't respond to previous treatments. The study will first check if the drug is safe and find the best dose. Then, it will see if this dose can help eliminate the cancer completely. Another treatment for this type of lymphoma is available for those who have not responded to multiple previous treatments.
Who is the study for?
This trial is for individuals with relapsed or refractory Large B-cell Lymphoma who have at least one measurable lesion and proper organ and bone marrow function. It's not suitable for those who don't meet these health requirements.
What is being tested?
The study tests KITE-197, alongside Cyclophosphamide and Fludarabine, in two phases: Phase 1a focuses on safety, tolerability, and dosing; Phase 1b assesses the effectiveness of KITE-197 at the recommended dose by looking at remission rates.
What are the potential side effects?
Potential side effects may include reactions to the infusion of KITE-197, as well as impacts from Cyclophosphamide and Fludarabine such as nausea, hair loss, mouth sores, decreased blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My large B-cell lymphoma has returned or is not responding to treatment.
Select...
It looks like there might be a mistake or missing information in your request. Could you please provide more details or clarify the criterion you'd like to have rewritten in simpler language?
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1b: Complete Remission (CR) Rate
Secondary study objectives
Duration of Response (DOR)
Event Free Survival (EFS)
Overall Response Rate (ORR)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: KITE-197Experimental Treatment3 Interventions
Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197.
Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2310
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Large B-Cell Lymphoma (LBCL) include chemotherapy, monoclonal antibodies, and CAR-T cell therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells.
Monoclonal antibodies, such as rituximab, target specific proteins on the surface of B-cells, marking them for destruction by the immune system. CAR-T cell therapy, like the investigational KITE-197, involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that specifically targets and kills B-cells.
These treatments are crucial for LBCL patients as they offer targeted approaches to eliminate cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
Fundamentals of the management of non-Hodgkin lymphoma.
Fundamentals of the management of non-Hodgkin lymphoma.
Find a Location
Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
3,920 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,303 Total Patients Enrolled