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Can donor immune cells be engineered to fight blood cancer?

NCT ID NCT05391490

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

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

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Feb 2040

An estimate. End dates often move.

Lead sponsor

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

16 to 65 years

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.

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University College London Hospital

    RECRUITING

    London, United Kingdom

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