Can donor immune cells be engineered to fight blood cancer?
NCT ID NCT05391490
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial tests a new type of cell therapy called KCAT19 for people aged 16 to 65 with advanced B-cell blood cancers that have relapsed or not responded to at least two prior treatments. The therapy uses immune cells from a donor's cord blood, which are modified to recognize and attack cancer cells. The study aims to see if these cells can be safely produced and given to patients, and to measure their effects on the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KCAT19 T cells, a type of engineered immune cell made from donor cord blood
- What this could lead to
- If successful, this approach could offer a new treatment option for people with advanced blood cancers that have not responded to standard therapies.
- What could go wrong
- This is an early-stage trial with a small number of participants. The treatment may cause severe side effects, and it is not yet known if it will be effective or safe for widespread use.
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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Feb 2040
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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16 to 65 years
- 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.
Inclusion Criteria: 1. Age 16-65 years 2. Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy: B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed/refractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed/ refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed / refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine. 3. CD19+ disease 4. Agreement to have a pregnancy test, use adequate contraception (if applicable) 5. Written informed consent Exclusion Criteria: 1. CD19 negative disease 2. Active CNS involvement of disease 3. Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma 4. Active hepatitis B, C or HIV infection 5. Oxygen saturation ≤ 90% on air 6. Bilirubin \>2 x upper limit of normal 7. GFR \<30ml/min 8. Women who are pregnant or breast feeding 9. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids 10. Karnofsky score \<60% 11. Known allergy to albumin or DMSO 12. Patients receiving corticosteroids at a dose of \>5 mg prednisolone per day (or equivalent) that cannot be discontinued 13. Life expectancy \<3 months 14. Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \<40% 15. Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\* * These patients will be initially considered for autologous treatment in preference to enrolling on KCAT19
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University College London Hospital
RECRUITINGLondon, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas