New immune cell therapy takes on tough lymphoma

NCT ID NCT06079164

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new treatment called KITE-197 for people with large B-cell lymphoma that has come back or not responded to other treatments. KITE-197 is made from a patient's own immune cells, which are modified in a lab to better attack cancer cells. The study will first check safety and dosing in a small group, then look at how well the recommended dose works in another group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KITE-197 (a CAR T-cell therapy made from the patient's own immune cells)
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat large B-cell lymphoma.
What could go wrong
This is a very early, small Phase 1 trial, so it may not work or could have serious side effects. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cross Cancer Institute

    Edmonton, T6G 1Z2, Canada

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Jewish General Hospital

    Montreal, H3T 1E2, Canada

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9, Canada

  • Royal Brisbane and Women's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

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