Multiple MyelomaPhase 1MCARTYNCT04795882
A New Study Evaluating the Activity of Modular CAR T for mYeloma
A Phase 1 study testing BCMA CAR T cells and BCMA/CD19 CAR T cells in people with Multiple Myeloma, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA CAR T cells and BCMA/CD19 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Apr 2022to 31 Mar 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Relapsed/Refractory Multiple Myeloma
- Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio.
- ≥3 prior lines of therapies (including proteasome inhibitor, IMiD, anti CD38 antibody)
- Refractory to last line of therapy (not achieved at least PR and progressed within 60 days of last dose or achieved at least PR but progressed within 6 months of last dose)
- Has previously received or is not suitable for ASCT
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- Eastern Cooperative Oncology Group (ECOG) performance status 0/1
- Creatinine Clearance (CrCl)≥40ml/min, Absolute Neutrophil Count (ANC)≥1x10^9/L, Platelets (plt)≥50x10^9/L, Haemoglobin (Hb)≥80 /L, lymphocyte count ≥0.3x10^9/L
- Patients must weigh >30 kg
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Who cannot join
- Previous diagnosis of systemic light chain amyloidosis
- Prior treatment with investigational or approved gene therapy or cell therapy products
- Stem cell transplant patients only:
- allogeneic stem cell transplant within 12 months prior to registration into the study
- moderate/ severe chronic GVHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
- Oxygen saturation ≤ 90% on air
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- Patients with clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event
- Left ventricular ejection fraction < 50% (ECHO or MUGA)
- Corrected QT interval (QTc)>470 ms on ECG
- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
- History or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at preconditioning
- Chronic renal impairment requiring dialysis
- Patients with significant liver disease: alanine aminotransferase or aspartate aminotransferase ≥3x upper limit normal (ULN), or total bilirubin ≥25umol/L (1.5mg/dL), except in patients with Gilbert's syndrome, or evidence of end-stage liver disease (e.g. ascites, hepatic encephalopathy)
- Patients with any major surgical intervention in the last 3 months, cement augmentation for vertebral collapse is permitted
- Patients with active gastrointestinal bleeding
- Patients with active infectious bacterial or viral disease requiring treatment
- Known active central nervous system involvement of MM. History or presence of clinically relevant central nervous system pathology such as epilepsy, paresis, aphasia, stroke within 3 months prior to enrolment, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis
- Patients receiving corticosteroids at a dose of >5 mg prednisolone per day (or equivalent) that cannot be discontinued
- Active autoimmune disease requiring immunosuppression
- Past or current history of other neoplasms
- Received any radiotherapy within the last 7 days prior to lymphodepletion or leukapheresis. Localised radiation to a single site, e.g. for bone pain is permitted at any time
- Patients with any anti-myeloma therapy within the last 7 days prior to LD or leukapheresis
- Inability to tolerate leucapheresis
- Life expectancy <3 months
- Women who are pregnant or breastfeeding
- Known allergy to albumin or DMSO
- Active infection requiring systemic anti-microbial therapy, or with temperature more or equal to 38 C within 48 hours before scheduled CAR-T cell infusion
- Requirement for supplementary oxygen at the time of scheduled CAR-T cell infusion
- Clinical deterioration of organ functions (hepatic or renal function) exceeding criteria set at study entry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lydia Lee contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, County (Optional)
Lydia Lee, Dr
About this study
Official title: An Open Label, Phase 1 Study Evaluating the Activity of Modular CAR T for mYeloma
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma.
The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.
Read the detailed description
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA CAR alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with triple refractory Multiple Myeloma.
The first 3-6 patients will be treated at the lower dose of BCMA CAR T cells in cohort 1 (50 x 10^6 cells). If the lower dose is deemed tolerable, recruitment into cohort 1 at a higher dose (150 x 10^6 BCMA CAR T cells) and cohort 2 at a dose of 50 x 10^6 BCMA/CD19 cells will begin in parallel.
- If the 50 x 10^6 cells BCMA/CD19 CAR dose in cohort 2 is deemed intolerable, then no further patients will be recruited to cohort 2.
- If both 150 x 10^6 cells BCMA CAR (cohort 1) and 50 x 10^6 cells BCMA/CD19 CAR (cohort 2) are deemed tolerable then recruitment will begin to a higher BCMA/CD19 CAR dose of 150 x 10^6 cells.
- If 150 x 10^6 cells BCMA CAR is intolerable and 50 x 10^6 cells BCMA/CD19 CAR is tolerable then no further patients will be recruited to cohorts 1 or 2.
With the 150x10^6 cells dose being deemed tolerable in both cohorts 1 and 2, a dose level 3 of 450x10^6 CAR T cells has been added to the design via a substantial amendment. Dose level 3 will first open in cohort 1 and, if deemed tolerable, will then proceed to be opened in cohort 2.
A Summary of dosing on trial is outlined below:
Cohort 1 (BCMA CAR-T cells)
- Dose level 1: 50x10^6 BCMA CAR-T cells
- Dose level 2: 150x10^6 BCMA CAR-T cells
- Dose level 3: 450x10^6 BCMA CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well)
Cohort 2 (BCMA/CD19 CAR-T cells)
- Dose level 1: 50x10^6 BCMA/CD19 CAR-T cells
- Dose level 2: 150x10^6 BCMA/CD19 CAR-T cells
- Dose level 3: 450x10^6 BCMA/CD19 CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well)
- Conditions
- Multiple Myeloma
- Being tested
- BCMA CAR T cells, BCMA/CD19 CAR T cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CAR T cellsBiological
Infusion with ATIMP: BCMA CAR T-cells
BCMA/CD19 CAR T cellsBiological
Infusion with ATIMP: BCMA/CD19 CAR T-cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BCMA CAR T cells | Experimental | Treatment with Advanced Therapy Investigational Product (ATIMP): BCMA CAR T-cells Receives: Biological: BCMA CAR T cells |
| Cohort 2: BCMA/CD19 CAR T cells | Experimental | Treatment with Advanced Therapy Investigational Product (ATIMP): BCMA/CD19 CAR T-cells Receives: Biological: BCMA/CD19 CAR 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 Advanced Therapy Investigational Product (ATIMP)
The incidence of grade 3-5 toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and the American Society for Transplantation and Cellular Therapy (ASTCT) Cytokine Release Syndrome (CRS) and Neurotoxicity tool
Measured: 28 days
Feasibility of manufacturing CAR T-cells evaluated by the number of therapeutic products generated
Feasibility of generation of CAR T cells as evaluated by the number of therapeutic products generated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start22 Apr 2022
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Rolling 6 trial design
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT04795882
- Sponsor's protocol ID
- UCL 129642
- Acronym
- MCARTY
- Status last verified
- Nov 2025
- First submitted
- 2 Mar 2021
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1 Study Evaluating the Activity of Modular CAR T for mYeloma
- ClinicalTrials.gov ID
- NCT04795882
- Acronym / sponsor ID
- MCARTY / UCL 129642
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 12 Mar 2021 (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.
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma.
The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.
Detailed description
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA CAR alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with triple refractory Multiple Myeloma.
The first 3-6 patients will be treated at the lower dose of BCMA CAR T cells in cohort 1 (50 x 10^6 cells). If the lower dose is deemed tolerable, recruitment into cohort 1 at a higher dose (150 x 10^6 BCMA CAR T cells) and cohort 2 at a dose of 50 x 10^6 BCMA/CD19 cells will begin in parallel.
- If the 50 x 10^6 cells BCMA/CD19 CAR dose in cohort 2 is deemed intolerable, then no further patients will be recruited to cohort 2.
- If both 150 x 10^6 cells BCMA CAR (cohort 1) and 50 x 10^6 cells BCMA/CD19 CAR (cohort 2) are deemed tolerable then recruitment will begin to a higher BCMA/CD19 CAR dose of 150 x 10^6 cells.
- If 150 x 10^6 cells BCMA CAR is intolerable and 50 x 10^6 cells BCMA/CD19 CAR is tolerable then no further patients will be recruited to cohorts 1 or 2.
With the 150x10^6 cells dose being deemed tolerable in both cohorts 1 and 2, a dose level 3 of 450x10^6 CAR T cells has been added to the design via a substantial amendment. Dose level 3 will first open in cohort 1 and, if deemed tolerable, will then proceed to be opened in cohort 2.
A Summary of dosing on trial is outlined below:
Cohort 1 (BCMA CAR-T cells)
- Dose level 1: 50x10^6 BCMA CAR-T cells
- Dose level 2: 150x10^6 BCMA CAR-T cells
- Dose level 3: 450x10^6 BCMA CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well)
Cohort 2 (BCMA/CD19 CAR-T cells)
- Dose level 1: 50x10^6 BCMA/CD19 CAR-T cells
- Dose level 2: 150x10^6 BCMA/CD19 CAR-T cells
- Dose level 3: 450x10^6 BCMA/CD19 CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Rolling 6 trial design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BCMA CAR T cells | Experimental | Biological: BCMA CAR T cellsTreatment with Advanced Therapy Investigational Product (ATIMP): BCMA CAR T-cells |
| Cohort 2: BCMA/CD19 CAR T cells | Experimental | Biological: BCMA/CD19 CAR T cellsTreatment with Advanced Therapy Investigational Product (ATIMP): BCMA/CD19 CAR T-cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18
- Relapsed/Refractory Multiple Myeloma
- Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio.
- ≥3 prior lines of therapies (including proteasome inhibitor, IMiD, anti CD38 antibody)
- Refractory to last line of therapy (not achieved at least PR and progressed within 60 days of last dose or achieved at least PR but progressed within 6 months of last dose)
Key exclusion criteria (29 listed)
- Previous diagnosis of systemic light chain amyloidosis
- Prior treatment with investigational or approved gene therapy or cell therapy products
- Stem cell transplant patients only:
- Oxygen saturation ≤ 90% on air
- Patients with clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event
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 |
|---|---|---|
| BCMA CAR T cellsInfusion with ATIMP: BCMA CAR T-cells | Biological | Cohort 1: BCMA CAR T cells |
| BCMA/CD19 CAR T cellsInfusion with ATIMP: BCMA/CD19 CAR T-cells | Biological | Cohort 2: BCMA/CD19 CAR T cells |
Primary outcome
Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the Advanced Therapy Investigational Product (ATIMP)
Time frame: 28 days
The incidence of grade 3-5 toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and the American Society for Transplantation and Cellular Therapy (ASTCT) Cytokine Release Syndrome (CRS) and Neurotoxicity tool
Feasibility of manufacturing CAR T-cells evaluated by the number of therapeutic products generated
Time frame: 30 days
Feasibility of generation of CAR T cells as evaluated by the number of therapeutic products generated.
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 20 Nov 2025.
- 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.
Lydia Lee contact
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 BCMA CAR T cells and BCMA/CD19 CAR T cells in people with Multiple Myeloma, 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 11 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
Contact MCARTY Trial Coordinator (02076799599, ctc.MCARTY@ucl.ac.uk), or a site near the patient. 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 Advanced Therapy Investigational Product (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 20 Nov 2025.