Rheumatoid Arthritis (RA)Phase 1CELL-ATTACK 1NCT07544225
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
A Phase 1 study testing anti-CD19 CAR-T cells in people with Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes
- What is being tested?
- anti-CD19 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2026to 1 Feb 2043
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 and ≤ 75 years of age at the time of inclusion visit.
- ECOG Performance status 0 to 2.
- Signed informed consent (or legal representative) must be obtained from the patient prior to participation in the study.
- Patients must have valid health insurance coverage in the country where the study is conducted.
- A diagnosis of treatment-refractory systemic autoimmune rheumatic disease (rheumatoid arthritis (RA), severe lupus erythematosus (SLE), Sjogren's disease (SjD), Systemic sclerosis (SSc) or idiopathic inflammatory myositis (IIM)) with a severe and progressive disease according to respective criteria below.
- Eligible patients must have failed at least two lines of conventional or biologic immunosuppressive therapies
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- Calculated creatinine clearance (calculated using CKD-EPI 2021 Formula) > 30 mL/min
- Women of childbearing potential must agree to use highly effective contraception or practice true sexual abstinence for at least 1 month before study start and until 12 months after CAR-T cells infusion. (see section 7.7 " Pregnancy and contraception ").
- Male patients must agree to practice true sexual abstinence or use condoms from 1 month before study start until 12 months after CAR-T cells infusion. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration (cf. section 7.7 " Pregnancy and contraception ").
- Patients shall be eligible to undergo CAR-T cells infusion
- Patients consents to give blood samples.
- Patients Patients must be located within one hour's driving distance from Gustave Roussy during the first 30 days after the injection and must be accompanied, as they should not drive during these initial 30 days
- Specific criteria for SLE:
- Diagnosis of SLE according to the 2019 ACR/EULAR classification criteria.
- Patient must be positive for at least one of the following autoantibodies at screening:
- anti-dsDNA (above the upper limit of normal, ULN) or
- anti-Sm (above ULN) or
- anti-nucleosome (above ULN) or
- anti-nuclear antibodies (ANA) and a decrease of C3 or C4
- Active severe disease with SLEDAI-2K ≥ 6
- Inadequate response or intolerance to at least 2 immunosuppressive treatments.
- Specific criteria for IIM:
- Confirmed or probable diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 EULAR/ACR classification criteria, including:
- Dermatomyositis (DM)
- Polymyositis (PM)
- Immune-mediated necrotizing myopathy (IMNM)
- Antisynthetase syndrome (ASS)
- Patient must be positive for at least one of the autoantibodies associated with IIM or anti-nuclear antibodies at screening (See, 24.3 Appendix 3 - List of Scleroderma- and Myositis-Specific Autoantibodies )
- Active myositis at baseline, demonstrated by at least one of the following:
- Elevated muscle enzymes (e.g., CPK > 1.5 × upper limit of normal)
- Manual Muscle Testing (MMT-8) score < 142/150
- Muscle MRI or EMG showing signs of active inflammation
- Progressive interstitial lung disease
- Inadequate response or intolerance to at least 2 immunosuppressive treatments.
- Specific criteria for SjD:
- Diagnosis of SjD as per 2016 ACR-EULAR criteria
- Documented seropositivity for SSA at screening or positive anti-nuclear antibodies associated with positive rheumatoid factor
- Active systemic disease defined as ESSDAI >5 points
- Refractory disease defined as inadequate response to hydroxychloroquine, glucocorticoids and oral immunosuppressive treatment, and otherwise requiring cyclophosphamide or rituximab, according to EULAR recommendations for the management of Sjogren's disease12. History of intolerance or inadequate response to rituximab or cyclophosphamide is also permitted.
- Specific criteria for RA
- RA diagnosis as per ACR/EULAR 2010 classification criteria
- Seropositivity for anti-citrullinated protein autoantibodies (ACPA) and/or rheumatoid factor (RF) at Screening
- Treatment according to EULAR recommendation and failure of ≥2 biologic/targeted synthetic Disease Modifying Anti Rheumatic Drug (DMARDs) after failing conventional synthetic DMARD therapy (unless contraindicated)
- Signs suggestive of active/progressive disease, defined as meeting all two below criteria at Screening:
- At least moderate disease activity (DAS28-CRP>3.2)
- Inflammatory activity confirmed by at least 1 swollen joints (documented by clinic or ultrasound)
- Specific criteria for SSc:
- Systemic sclerosis as per the 2013 ACR/EULAR Classification Criteria
- CT scan evidence of interstitial lung disease
- Severe skin involvement with mRSS>10
- EUSTAR AI >2,5
- Resistance or intolerance to at least two Disease Modifying Anti Rheumatic Drugs (DMARDs).
Who cannot join
- Any significant active infection, including:
- Active hepatitis B (defined by detectable HBV DNA) or C infection (defined by detectable HCV RNA),
- Known HIV infection,
- Previous treatment with any gene therapy product or CAR-T cells therapy.
- Inadequate organ function during screening
- Inadequate renal function is defined as eGFR ≤30mL/min/1.73m2 using the the Cockcroft-Gault Formula
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- Inadequate hepatic function is defined as any of the following:
- defined by Child-Pugh class B or C
- ALT and AST above 2 × ULN
- TBL > 1.5 × ULN with the exception of participants with Gilbert's syndrome or patients with a positive Coombs test and evidence of hemolysis, who may be included if their TBL is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN
- International normalized ratio (INR) > 1.5
- Inadequate cardiac function is defined as LVEF < 50% as determined by ultra-sonography performed at screening
- Inadequate lung function requiring continuous oxygenotherapy
- Active malignancy or history of cancer within the past 2 years (except successfully treated localized skin basal or squamous cell carcinoma, or cervical carcinoma in situ).
- History of allogeneic hematopoietic tem cell transplantation or solid organ transplantation.
- Pregnancy or breastfeeding.
- Women of childbearing potential and fertile men who do not agree to use highly effective contraception or maintain sexual abstinence during the study and for 12 months after CAR-T cells infusion.
- Any acute, severe disease flare at and during screening that needs immediate treatment other than pulse glucocorticoids and/or makes the immunosuppressive washout impossible
- Clinically significant active, opportunistic, chronic or recurrent infection
- Any patients requiring medications prohibited by the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Gustave Roussy
Villejuif, Val de Marne, 94805
Cristina CASTILLA-LLORENTE, +33(0)142114355, Cristina.castilla-llorente@gustaveroussy.fr
About this study
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM)
- Being tested
- anti-CD19 CAR-T cells
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR-T cellsBiological
The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight Receives: Biological: anti-CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion
Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either:
- Cytokine Release Syndrome (CRS) ≥ grade 3 or,
- Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or,
- Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3
Measured: from CAR-T cells infusion to 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544225
- Sponsor's protocol ID
- 2026-526552-32-00
- Other IDs
- 2026/4318
- Acronym
- CELL-ATTACK 1
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT07544225
- Acronym / sponsor ID
- CELL-ATTACK 1 / 2026-526552-32-00
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2043 (estimated)
- First posted
- 22 Apr 2026 (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 an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: anti-CD19 CAR-T cellsThe anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (52 listed)
- Patients ≥ 18 and ≤ 75 years of age at the time of inclusion visit.
- ECOG Performance status 0 to 2.
- Signed informed consent (or legal representative) must be obtained from the patient prior to participation in the study.
- Patients must have valid health insurance coverage in the country where the study is conducted.
- A diagnosis of treatment-refractory systemic autoimmune rheumatic disease (rheumatoid arthritis (RA), severe lupus erythematosus (SLE), Sjogren's disease (SjD), Systemic sclerosis (SSc) or idiopathic inflammatory myositis (IIM)) with a severe and progressive disease according to respective criteria below.
Key exclusion criteria (20 listed)
- Any significant active infection, including:
- Previous treatment with any gene therapy product or CAR-T cells therapy.
- Inadequate organ function during screening
- Active malignancy or history of cancer within the past 2 years (except successfully treated localized skin basal or squamous cell carcinoma, or cervical carcinoma in situ).
- History of allogeneic hematopoietic tem cell transplantation or solid organ transplantation.
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 |
|---|---|---|
| anti-CD19 CAR-T cellsThe anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight | Biological | Treatment |
Primary outcome
Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion
Time frame: from CAR-T cells infusion to 30 days post-treatment
Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either: * Cytokine Release Syndrome (CRS) ≥ grade 3 or, * Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or, * Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3
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 2 Sep 2026.
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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.
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 anti-CD19 CAR-T cells in people with Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 52 inclusion and 20 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: opening soon, as of the sponsor's last update on 2 Sep 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 France. 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 Cristina CASTILLA-LLORENTE (+33(0)142114355, Cristina.castilla-llorente@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion (time frame: from CAR-T cells infusion to 30 days post-treatment). 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 2 Sep 2026.