Blood CancerPhase 1KCAT19NCT05391490
Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies
A Phase 1 study testing KCAT19 T cells in people with Blood Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Blood Cancer
- What is being tested?
- KCAT19 T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2023to Feb 2040
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-65 years
- 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.
- CD19+ disease
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Who cannot join
- CD19 negative disease
- Active CNS involvement of disease
- Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤ 90% on air
- Bilirubin >2 x upper limit of normal
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- GFR <30ml/min
- Women who are pregnant or breast feeding
- 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
- Karnofsky score <60%
- Known allergy to albumin or DMSO
- Patients receiving corticosteroids at a dose of >5 mg prednisolone per day (or equivalent) that cannot be discontinued
- Life expectancy <3 months
- Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction <40%
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Day contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
About this study
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.
Read the detailed description
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).
- Conditions
- Blood Cancer
- Being tested
- KCAT19 T cells
- Keywords
- CAR T cells, leukemia, lymphoma
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KCAT19 T cellsGenetic
Allogeneic, cord unit derived KCAT19 T cells
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Trial | Experimental | Treatment with Lymphodepletion followed by a dose of KCAT19 T cells. Receives: Genetic: KCAT19 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 28 days after last patient treated
Secondary outcomes (7)
Response rate
Proportion of responders and depth of response at 1 and 6 months post ATIMP infusion
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years after last patient treated
Time to Disease Progression
Time to Disease Progression
Measured: 2 years after last patient treated
Event-Free survival
Event-Free Survival at 1 and 2 years after immunotherapy with KCAT19 T cells
Measured: 2 years after last patient treated
Overall Survival
Overall survival at 1 and 2 years after immunotherapy with KCAT19 T cells
Measured: 2 years after last patient treated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start6 Feb 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP)
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391490
- Sponsor's protocol ID
- UCL/126900
- Other IDs
- 2021-002878-88
- Acronym
- KCAT19
- Status last verified
- Aug 2026
- First submitted
- 16 May 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No