Primary CNS LymphomaPhase 1CAROUSELNCT04443829
Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary CNS Lymphoma
A Phase 1 study testing CD19CAR T-cells in people with Primary CNS Lymphoma, run by University College, London at 1 site in United Kingdom.
Trial summary
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Primary CNS Lymphoma
- What is being tested?
- CD19CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2021to Dec 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥16
- Patients with a histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) confined to the CNS (Primary CNS Lymphoma (PCNSL))
- Relapsed* or refractory CD19+ PCNSL, defined as disease progression following CR/CRu/PR, or failure to achieve PR, after one or more lines of a high-dose methotrexate-containing protocol *Histological confirmation by re-biopsy at relapse is recommended if feasible. However, patients will be eligible without re-biopsy provided the initial diagnostic material is available and current MRI imaging features are consistent with PCNSL by neuroradiology review.
- Measurable disease on contrast-enhanced MRI
- Unsuitable for alternative salvage therapies as determined by their treating physician
- Agreement to have a pregnancy test, use highly effective contraception (if applicable)
- Written informed consent Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases a legal representative may be sought to provide consent'.
Who cannot join
- CD19 negative disease
- Evidence of secondary CNS lymphoma
- Prior allogeneic haematopoietic stem cell transplant
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤90% on air
- Bilirubin >2 x upper limit of normal
Show all 26Show fewer
- Glomerular Filtration Rate (GFR) <50ml/min
- Women who are pregnant or breast feeding
- Inability to tolerate leucapheresis
- ECOG 3-4
- Known allergy to albumin or Dimethyl sulfoxide (DMSO)
- Life expectancy <3months
- Arrhythmias or significant cardiac disease and left ventricular ejection fraction <40%
- Pre-existing neurological disorders (other than CNS involvement of underlying haematological malignancy)
- Any contraindications to PD-1 antibody Pembrolizumab
- History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months
- Evidence of active pneumonitis on chest computed tomography (CT) or positron emission tomography (PET)-CT scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), or idiopathic pneumonitis. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed (if >24 weeks since the event)
- Exclusion criteria: for CD19CAR T-cell infusion ( Dose 1/i.v. and Dose 2/intraventricular):
- Severe intercurrent infection at the time of scheduled CD19CAR T-cell infusion
- Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19CAR T-cell infusion
- Theme 2 only:
- presence of grade 3 or 4 ICANS casually related to the ATIMP following infusion of Dose 1
- grade 1-2 neurotoxicity (if occurred) following Theme 1 dosing (Dose 1/i.v CD19CAR Tcell dose) that has not fully resolved prior to proposed administration of 2nd CD19CAR T-cell infusion (Dose /intraventricular) for theme 2
- grade 3-4 CRS following infusion of Dose 1
- persisting grade 2 CRS following Theme 1 dosing (Dose 1/i.v CD19CAR T-cell dose) that has not resolved to ≤ grade 1 CRS prior to proposed administration of 2nd CD19CAR Tcell infusion (Dose 2/intraventricular) for theme 2
- pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, WC1E6BT
About this study
Official title: Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary Central Nervous System (CNS) Lymphoma
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma.
The study will evaluate the feasibility of generating the ATIMP, the safety of administering CD19CAR T-cell therapy and how effectively CD19CAR T-cells engraft, expand and persist following administration in patients with relapsed/refractory primary CNS lymphoma.
Read the detailed description
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma. The ATIMP for this study is cryopreserved autologous patient-derived T-cells transduced with CD19CAR vector to generate CD19CAR T-cells.
Patients will undergo an unstimulated leucapheresis for the generation of the ATIMP which will take approximately 15 days to generate. During this period, patients may receive "holding" chemotherapy as per institutional practice to maintain disease control. Patients will receive pre-conditioning lymphodepleting (LD) chemotherapy with cyclophosphamide 60mg/kg on Day -6, fludarabine 30mg/m2 administered over 3 days (Day -5 to Day -3) and pembrolizumab 200mg on Day -1.
All patients will be treated on Theme 1 of the study with 250 x 10^6 CD19 CAR T-cells i.v. following LD chemotherapy as described above. Patients with response of Stable Disease (SD) or Progressive Disease (PD) at Day 28 (or frank relapse beyond Day 28) and in the absence of severe toxicity related to the ATIMP, will be potentially eligible for Theme 2 of the study where they can receive Dose 2, a single dose of 25 x 10^6 CD19CAR T-cells intraventricularly via an Ommaya reservoir following LD chemotherapy as described above.
The study will evaluate the feasibility of generating the ATIMP, the safety of administering CD19CAR T-cell therapy and how effectively CD19CAR T-cells engraft, expand and persist following administration in patients with relapsed/refractory primary CNS lymphoma.
Following infusion of CD19CAR T-cell therapy patients will be monitored for between 2-4 weeks as an inpatient. Following discharge, patients will enter the interventional follow up phase and be followed up for 2 years. Patients will be seen monthly for the first 6 months, then 6 weekly to 12 months and then 3 monthly until 2 years post CD19CAR T-cell infusion.
If patients relapse within the first 2 years post CD19CAR T-cell infusion they will come off the interventional follow up and will be followed up annually until the end of trial is declared.
After completing the interventional phase of the study all patients, irrespective of whether they progressed or responded to treatment, will enter long term follow up until the end of trial is declared.
- Conditions
- Primary CNS Lymphoma
- Being tested
- CD19CAR T-cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19CAR T-cellsBiological
Infusion with: CD19CAR T-cells
| Study group | Role | What they receive |
|---|---|---|
| CD19CAR T-cells | Experimental | Treatment with the ATIMP: CD19CAR T-cells Receives: Biological: CD19CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Toxicity following CD19CAR T-cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Measured: 28 days
Feasibility of manufacturing CD19CAR T-cells evaluated by the number of therapeutic products generated
Feasibility of adequate leucapheresis collection and generation of CD19CAR T-cells as evaluated by the number of therapeutic products generated.
Measured: 28 days
Secondary outcomes (6)
Response at 1 and 3 months
Proportion of patients achieving a Complete Response (CR) or Partial Response (PR) at 1 and 3 months post CD19CAR T-cells infusion: Theme 1 (i.v.) and Theme 2 (intraventricular)
Measured: From CD19CAR T-cells infusion to 1 and 3 months
Frequency of circulating CD19CAR T-cells in peripheral blood
Frequency of circulating CD19CAR T-cells in peripheral blood as assessed by flow cytometry and qPCR
Measured: From CD19CAR T-cells infusion up to 2 years post CD19CAR T-cells infusion
Incidence of B-cell aplasia
Incidence of B-cell aplasia
Measured: From CD19CAR T-cells infusion up to 2 years post CD19CAR T-cells infusion
Relapse rate at 1 and 2 years
Proportion of patients who have relapsed at 1 and 2 years after CD19CAR T-cells infusion
Measured: At 1 year and 2 years after CD19CAR T-cells infusion
Progression Free Survival (PFS) at 1 and 2 years
Progression Free Survival at 1 and 2 years after CD19CAR T-cells infusion
Measured: At 1 year and 2 years after CD19CAR T-cells infusion
Overall Survival (OS) at 1 and 2 years
Overall Survival at 1 and 2 years after immunotherapy with CD19CAR T-cells infusion
Measured: At 1 year and 2 years after CD19CAR T-cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start23 Mar 2021
- Primary completion30 Dec 2024
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CNS LymphomaStudies 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
- 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
- Investigators
- Claire Roddie, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443829
- Sponsor's protocol ID
- UCL/126892
- Acronym
- CAROUSEL
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2020
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary Central Nervous System (CNS) Lymphoma
- ClinicalTrials.gov ID
- NCT04443829
- Acronym / sponsor ID
- CAROUSEL / UCL/126892
- Conditions
- Primary CNS Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- Dec 2032 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma.
The study will evaluate the feasibility of generating the ATIMP, the safety of administering CD19CAR T-cell therapy and how effectively CD19CAR T-cells engraft, expand and persist following administration in patients with relapsed/refractory primary CNS lymphoma.
Detailed description
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma. The ATIMP for this study is cryopreserved autologous patient-derived T-cells transduced with CD19CAR vector to generate CD19CAR T-cells.
Patients will undergo an unstimulated leucapheresis for the generation of the ATIMP which will take approximately 15 days to generate. During this period, patients may receive "holding" chemotherapy as per institutional practice to maintain disease control. Patients will receive pre-conditioning lymphodepleting (LD) chemotherapy with cyclophosphamide 60mg/kg on Day -6, fludarabine 30mg/m2 administered over 3 days (Day -5 to Day -3) and pembrolizumab 200mg on Day -1.
All patients will be treated on Theme 1 of the study with 250 x 10^6 CD19 CAR T-cells i.v. following LD chemotherapy as described above. Patients with response of Stable Disease (SD) or Progressive Disease (PD) at Day 28 (or frank relapse beyond Day 28) and in the absence of severe toxicity related to the ATIMP, will be potentially eligible for Theme 2 of the study where they can receive Dose 2, a single dose of 25 x 10^6 CD19CAR T-cells intraventricularly via an Ommaya reservoir following LD chemotherapy as described above.
The study will evaluate the feasibility of generating the ATIMP, the safety of administering CD19CAR T-cell therapy and how effectively CD19CAR T-cells engraft, expand and persist following administration in patients with relapsed/refractory primary CNS lymphoma.
Following infusion of CD19CAR T-cell therapy patients will be monitored for between 2-4 weeks as an inpatient. Following discharge, patients will enter the interventional follow up phase and be followed up for 2 years. Patients will be seen monthly for the first 6 months, then 6 weekly to 12 months and then 3 monthly until 2 years post CD19CAR T-cell infusion.
If patients relapse within the first 2 years post CD19CAR T-cell infusion they will come off the interventional follow up and will be followed up annually until the end of trial is declared.
After completing the interventional phase of the study all patients, irrespective of whether they progressed or responded to treatment, will enter long term follow up until the end of trial is declared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19CAR T-cells | Experimental | Biological: CD19CAR T-cellsTreatment with the ATIMP: CD19CAR T-cells |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥16
- Patients with a histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) confined to the CNS (Primary CNS Lymphoma (PCNSL))
- Relapsed* or refractory CD19+ PCNSL, defined as disease progression following CR/CRu/PR, or failure to achieve PR, after one or more lines of a high-dose methotrexate-containing protocol *Histological confirmation by re-biopsy at relapse is recommended if feasible. However, patients will be eligible without re-biopsy provided the initial diagnostic material is available and current MRI imaging features are consistent with PCNSL by neuroradiology review.
- Measurable disease on contrast-enhanced MRI
- Unsuitable for alternative salvage therapies as determined by their treating physician
Key exclusion criteria (26 listed)
- CD19 negative disease
- Evidence of secondary CNS lymphoma
- Prior allogeneic haematopoietic stem cell transplant
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤90% on air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19CAR T-cellsInfusion with: CD19CAR T-cells | Biological | CD19CAR T-cells |
Primary outcome
Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Time frame: 28 days
Toxicity following CD19CAR T-cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Feasibility of manufacturing CD19CAR T-cells evaluated by the number of therapeutic products generated
Time frame: 28 days
Feasibility of adequate leucapheresis collection and generation of CD19CAR T-cells as evaluated by the number of therapeutic products generated.
6 secondary outcomes
Response at 1 and 3 months
Time frame: From CD19CAR T-cells infusion to 1 and 3 months
Frequency of circulating CD19CAR T-cells in peripheral blood
Time frame: From CD19CAR T-cells infusion up to 2 years post CD19CAR T-cells infusion
Incidence of B-cell aplasia
Time frame: From CD19CAR T-cells infusion up to 2 years post CD19CAR T-cells infusion
Relapse rate at 1 and 2 years
Time frame: At 1 year and 2 years after CD19CAR T-cells infusion
Progression Free Survival (PFS) at 1 and 2 years
Time frame: At 1 year and 2 years after CD19CAR T-cells infusion
Overall Survival (OS) at 1 and 2 years
Time frame: At 1 year and 2 years after CD19CAR T-cells infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Roddie study chair
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19CAR T-cells in people with Primary CNS Lymphoma, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.