New immune cell therapy takes on tough lymphoma
NCT ID NCT06079164
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Nov 2023
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
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Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
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Jewish General Hospital
Montreal, H3T 1E2, Canada
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QEII Health Sciences Centre
Halifax, B3H 2Y9, Canada
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Royal Brisbane and Women's Hospital
South Brisbane, Queensland, 4101, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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St. David's South Austin Medical Center
Austin, Texas, 78704, United States
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Swedish Cancer Institute
Seattle, Washington, 98104, United States
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Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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The Alfred Hospital
Melbourne, Victoria, 3004, Australia
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a One-Time infusion of Dual-Target CAR-T cells outsmart resistant blood cancers?
- New combo therapy aims to boost remission in Hard-to-Treat lymphoma
- Experimental CAR T-Cell therapy targets tough lymphoma
- Automated CAR-T therapy shows promise for Tough-to-Treat lymphoma
- New hope for lymphoma patients: glofitamab combo faces standard care in trial
- Double-Barreled attack: CAR-T plus stem cell transplant takes on aggressive lymphoma