A Phase 1 interventional study of KCAT19 T cells in Blood Cancer, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University College, London · Phase 1, Interventional, and Treatment
Among 70 studies in Hematologic Neoplasms with a site in United Kingdom — 22 open to participants now, 28 under way, 11 of them phase 3. Hematologic Neoplasms · United Kingdom.
Among the 70 studies in Hematologic Neoplasms with a site in United Kingdom, this one is the 58th largest by planned enrollment of the 61 interventional ones, is one of 7 that started in 2023, is one of 15 in phase 1, reaches primary completion later than 4 of the 27 other live ones, and was the 50th registered.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 12 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →22 of the 70 studies in Hematologic Neoplasms with a site in United Kingdom are open now, in 12 countries. Each count lists the studies.
Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.
This study: 16 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →70 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 7 started in 2023.
Median enrollment 77 across the 61 interventional studies, 200 across the 9 observational. Of the 37 that completed or were terminated, 18 (49%) have results posted.
47 of 70 have an industry lead sponsor. The 10 most frequent:
University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
University College, London has 2 studies filed under Hematologic Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Hematologic Neoplasms with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401356Phase 3Novartis PharmaceuticalsAn Extension Study for Patients Previously Enrolled in Studies With Pelabresib | 2027-06-02 |
| NCT06782373Swedish Orphan BiovitrumA Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) | 2026-12-30 |
| NCT05391490University College, LondonAllogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies | 2027-02 |
| NCT05428969Faron Pharmaceuticals LtdA Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies | 2027-03 |
| NCT06645886Kumquat Biosciences Inc.A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies | 2027-03 |
Among the 70 studies in Hematologic Neoplasms with a site in United Kingdom, from their registry updates:
KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed/refractory (r/r) B cell malignancies.
The aims of this study are to make sure these KCAT19 T cells can be made in the lab, assess if these therapies are safe and also obtain some initial information that these CAR T cells work in patients with B-cell malignancies.
Following patent's informed consent and registration into the trial, allogeneic HLA-matched cord blood donor T cells will be couriered to the Centre for Cell, Gene \& Tissue Therapeutics (CCGTT) at the Royal Free Hospital (RFH) where the KCAT19 T cells will be manufactured. The first 3 patients treated on KCAT19 will be HLA matched 4-6/6 with a cord-blood donor and the remaining patients registered will be HLA matched 0-6/6 if confirmed by the IDMC.
KCAT19 T cells are classified as advanced therapy investigational medicinal products (ATIMPs) and manufacture will take approximately 15 days.
Briefly, the allogeneic cord-blood derived T cells are grown in the presence of a lentivirus which transfers specific genes into the T cells (part of the white blood cells). The genes enable the T cells to express a protein which can recognise a target protein (CD19) present on the surface of the malignant B-cells and attack them. The genetically modified cells are tested to ensure they comply with the specified quality release criteria and frozen at RFH. The ATIMPs are couriered to the trial site with a special shipper (maintaining temperature below -130C) to be administered to the patient when needed. During the ATIMP manufacturing period, patients may receive "holding" chemotherapy or immunotherapy as per institutional practice to maintain disease control. Prior to infusion of the KCAT19 T cells, patients will be admitted to hospital to have pre-conditioning therapy with 2 anticancer drugs: cyclophosphamide and fludarabine.
Patients will then receive the KCAT19 T cell infusion on day 0. The KCAT19 T cells are given as an intravenous infusion. Patients will be closely monitored at the participating trial site for a minimum of 14 days after the KCAT19 T cells infusion with regular observations and blood tests (detailed in the protocol) to assess for potential toxicities. Disease assessment will take place at; baseline, month 1, month 6 and month 12 post-KCAT19 T cell infusion.
Following discharge, patients will be followed up monthly for the first 6 months, then 6 weekly until 12 months post KCAT19 T infusion, followed by quarterly visits for a further year before annual visits until the end of the trial is declared (Year 3 - Year 10).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
B cell following at least 2 :
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.
Exclusion Criteria:
Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial*
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Lymphodepletion followed by a dose of KCAT19 T cells.
Genetic: KCAT19 T cells
Allogeneic, cord unit derived KCAT19 T cells
KCAT 19 T cell generation feasibility
Feasibility of generation of T cell receptor-negative KCAT19 T cells as evaluated by the number of therapeutic products generated.
Time frame: Up to 28 days after last patient is recruited
KCAT19 T cell Toxicity
Toxicity following KCAT19 T cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Time frame: Up to 28 days after last patient treated
Response rate
Proportion of responders and depth of response at 1 and 6 months post ATIMP infusion
Time frame: 6 months after last patient treated with ATIMP
KCAT19 T cell persistence
Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by flow cytometry
Time frame: After last treated patient completes the 2 year follow up visit
KCAT19 T cell persistence
Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by qPCR
Time frame: After last treated patient completes the 2 year follow up visit
Hypogammaglobulinaemia and B cell aplasia
Incidence and duration of hypogammaglobulinaemia and B cell aplasia
Time frame: 2 years after last patient treated
Time to Disease Progression
Time to Disease Progression
Time frame: 2 years after last patient treated
Event-Free survival
Event-Free Survival at 1 and 2 years after immunotherapy with KCAT19 T cells
Time frame: 2 years after last patient treated
Overall Survival
Overall survival at 1 and 2 years after immunotherapy with KCAT19 T cells
Time frame: 2 years after last patient treated
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2027, 48 months after the start.
Of 64 non-industry phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 88. This study's planned 48 months is below that.
Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.