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Relapsed/Refractory Large B-cell LymphomaPhase 1NCT06079164

Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

A Phase 1 study testing KITE-197, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 11 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KITE-197, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
11 sitesin 3 countries
Study dates
9 Nov 2023to Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or Refractory Large B-cell Lymphoma
  • At least 1 measurable lesion
  • Adequate organ and bone marrow function

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

United States5 sites

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Swedish Cancer Institute

    Seattle, Washington, 98104

Other trials in United States

Australia3 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Brisbane and Women's Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Canada3 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9

  • Jewish General Hospital

    Montreal, H3T 1E2

Other trials in Canada

About this study

Official title: 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 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.

Read the detailed description

Participants will be followed for approximately 6 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in which they will be followed for the remainder of the 15-year follow-up period.

Being tested
KITE-197, Cyclophosphamide, Fludarabine
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KITE-197Drug

    A single infusion of CAR-transduced autologous T cells administered intravenously

  • CyclophosphamideDrug

    Lymphodepleting chemotherapy administered intravenously

  • FludarabineDrug

    Lymphodepleting chemotherapy administered intravenously

Study groups in NCT06079164
Study groupRoleWhat they receive
KITE-197ExperimentalPhase 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.
Receives: Drug: KITE-197; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)

    Measured: First infusion date of KITE-197 up to 28 days

  2. Phase 1b: Complete Remission (CR) Rate

    Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Percentage of Participants Experiencing Adverse Events (AEs)

    Measured: Enrollment up to 24 months plus 30 days

  2. Percentage of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Enrollment up to 24 months plus 30 days

  3. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.

    Measured: Up to 24 months

  4. Duration of Response (DOR)

    DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.

    Measured: Up to 24 months

  5. Progression-Free Survival (PFS)

    PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.

    Measured: Up to 24 months

  6. Event Free Survival (EFS)

    EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.

    Measured: Up to 24 months

  7. Time to Next Treatment (TTNT)

    TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.

    Measured: Up to 24 months

  8. Overall Survival (OS)

    OS is defined as the time from KITE-197 infusion to death from any cause.

    Measured: Up to 24 months

  9. Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion

    Measured: Up to 24 months

  10. Proportion of Immune Cell Subsets in KITE-197

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start9 Nov 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079164
Sponsor's protocol ID
KT-US-656-0601
Status last verified
Aug 2026
First submitted
6 Oct 2023
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KITE-197, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) (time frame: First infusion date of KITE-197 up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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