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Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
NCT06079164 · View on ClinicalTrials.gov ↗
Study Summary
This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL. The primary objectives of this study are: Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b. Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG KITE-197
Study Locations (11)
Other
- Cross Cancer Institute — Edmonton
- QEII Health Sciences Centre — Halifax
- Jewish General Hospital — Montreal
Florida
- Sylvester Comprehensive Cancer Center — Miami
Illinois
- University of Chicago Medical Center — Chicago
Tennessee
- Henry-Joyce Cancer Clinic — Nashville
Texas
- St. David's South Austin Medical Center — Austin
Washington
- Swedish Cancer Institute — Seattle
New South Wales
- Royal Prince Alfred Hospital — Camperdown
Queensland
- Royal Brisbane and Women's Hospital — South Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-11-09 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06079164
The ClinicalTrials.gov registry entry for NCT06079164 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kite, A Gilead Company, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Relapsed/Refractory Large B-cell Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06079164 reports 11 study locations spanning 9 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06079164 about?
NCT06079164 is a clinical study titled "Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma". This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical st...
What is the current status of trial NCT06079164?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2023-11-09. Estimated completion is 2026-07.
What conditions does trial NCT06079164 study?
This clinical trial studies the following conditions: Relapsed/Refractory Large B-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06079164?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), KITE-197 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06079164?
This trial is sponsored by Kite, A Gilead Company, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06079164 being conducted?
This trial has 11 study locations across Florida, Illinois, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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