Systemic Sclerosis (SSc)Phase 1NCT07854483
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy
A Phase 1 study testing C-CAR168 in people with Systemic Sclerosis (SSc) and Systemic Sclerosis, run by AbelZeta Inc. at 1 site in United States.
Trial summary
This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory Systemic Sclerosis (SSc) who are not responding to standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis (SSc), Systemic Sclerosis, Systemic Sclerosis (Scleroderma)
- What is being tested?
- C-CAR168
- 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 States
- Study dates
- Mar 2027to Mar 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign and date the Informed Consent Form (ICF).
- Female or male, aged 18-70 years (inclusive) with body weight ≥40 kg.
- Have a clinical diagnosis of diffuse cutaneous SSc according to the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification.
- Disease duration between the onset of the first non-Raynaud's sign/symptom and ICF signing shall be ≤ 6 years.
- SSc Disease Activity meet all following criteria:
- Modified Rodnan Skin Score (mRSS) ≥15.
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- Chest High Resolution Computed Tomography (HRCT) shows SSc related ground-glass opacities.
- Percent predicted forced vital capacity (ppFVC)<70% or precent predicted (diffusing capacity of the lungs for carbon monoxide) ppDLco<70%.
- Positivity for at least one SSc-specific autoantibodies:
- anti-Scl70 antibody.
- anti-RNA polymerase III antibody.
- anti-centromere antibody.
- anti-Th/To antibody.
- and anti-U3RNP antibody.
- Refractory to at least two prior standard-of-care regimens, including immunosuppressives and/or a biologic note: "Refractory" is defined as receiving each listed drug for ≥6 months with either no response, disease progression after transient remission, or persistent disease progression on treatment.
- Ability to taper steroids to protocol allowed doses
Who cannot join
- ppFVC<45% or ppDLco <40%.
- Severe pulmonary arterial hypertension (PAH) as measured by screening echocardiogram (ECHO), or had documented mean positive airway pressure PAP (mPAP) > 45mmHg on recent right heart catheterization (RHC).
- Note: RHC is not mandatory at screening, however participant with high-risk ECHO findings warrant close clinical vigilance, and participant with mPAP> 45mmHg at baseline shall not proceed with lymphodepletion.
- Presence of clinically significant abnormalities on chest high-resolution computed tomography (HRCT) that are UNRELATED to SSc.
- Cutaneous sclerosis that impedes venous access required for leukapheresis, lymphodepletion, C-CAR168 infusion, other study procedures and emergency rescue interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center, Phase 1b Clinical Study of an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy (C-CAR168) for the Treatment of Systemic Sclerosis (SSc) Refractory to Standard Therapy
This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory Systemic Sclerosis (SSc) who are not responding to standard therapy. Approximately 6-12 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of C-CAR168. Participants will be followed for 24 months (2 years) to evaluate safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, biomarkers, and preliminary efficacy results. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis, Systemic Sclerosis (Scleroderma), Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria, Systemic Sclerosis Pulmonary, Systemic Sclerosis With Lung Involvement
- Being tested
- C-CAR168
- Keywords
- Autoimmune, CAR-T, CAR T-cell Therapy, Systemic Sclerosis, SSc, Autoimmune disease, CD20, BCMA, CAR-T Therapy, Chimeric Antigen Receptor T cell, chimeric antigen receptor T-cell Therapy
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR168Biological
Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| C-CAR168 | Experimental | Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168 Receives: Biological: C-CAR168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events
Incidence and severity of treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, CRS, ICANS, adverse events of special interest, and treatment- or procedure-related adverse events.
Measured: Through Month 24
Secondary outcomes (6)
Proportion of Participants Achieving Response
Proportion of participants achieving a response per the revised Composite Response Index for Systemic Sclerosis (r-CRISS)
Measured: Through Month 24
Pharmacokinetics of C-CAR168 Utilizing Flow Cytometry
Characterize T-cell expansion and persistence utilizing flow cytometry
Measured: Through Month 24
Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)
Characterize CAR T-cell expansion and persistence using qPCR
Measured: Through Month 24
Proportion of Participants Progressed
Proportion of participants that progress meeting any of the protocol defined progression criteria
Measured: Through Month 24
Time to First Response
Time to participant meeting first response as defined in the protocol
Measured: Through Month 24
Duration of Response (DOR)
Time of response from first response until progression as defined in the protocol
Measured: Through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- 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
- AbelZeta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yihong Yao, PhD, Study director, AbelZeta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854483
- Sponsor's protocol ID
- ABZT-413
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase 1b Clinical Study of an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy (C-CAR168) for the Treatment of Systemic Sclerosis (SSc) Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT07854483
- Acronym / sponsor ID
- ABZT-413
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis, Systemic Sclerosis (Scleroderma), Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria, Systemic Sclerosis Pulmonary, Systemic Sclerosis With Lung Involvement
- Keywords
- Autoimmune, CAR-T, CAR T-cell Therapy, Systemic Sclerosis, SSc, Autoimmune disease, CD20, BCMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AbelZeta Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Oct 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 Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory Systemic Sclerosis (SSc) who are not responding to standard therapy. Approximately 6-12 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of C-CAR168. Participants will be followed for 24 months (2 years) to evaluate safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, biomarkers, and preliminary efficacy results. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CAR168 | Experimental | Biological: C-CAR168Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to sign and date the Informed Consent Form (ICF).
- Female or male, aged 18-70 years (inclusive) with body weight ≥40 kg.
- Have a clinical diagnosis of diffuse cutaneous SSc according to the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification.
- Disease duration between the onset of the first non-Raynaud's sign/symptom and ICF signing shall be ≤ 6 years.
- SSc Disease Activity meet all following criteria:
Key exclusion criteria (5 listed)
- ppFVC<45% or ppDLco <40%.
- Severe pulmonary arterial hypertension (PAH) as measured by screening echocardiogram (ECHO), or had documented mean positive airway pressure PAP (mPAP) > 45mmHg on recent right heart catheterization (RHC).
- Note: RHC is not mandatory at screening, however participant with high-risk ECHO findings warrant close clinical vigilance, and participant with mPAP> 45mmHg at baseline shall not proceed with lymphodepletion.
- Presence of clinically significant abnormalities on chest high-resolution computed tomography (HRCT) that are UNRELATED to SSc.
- Cutaneous sclerosis that impedes venous access required for leukapheresis, lymphodepletion, C-CAR168 infusion, other study procedures and emergency rescue interventions.
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 |
|---|---|---|
| C-CAR168Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion | Biological | C-CAR168 |
Primary outcome
Incidence and severity of treatment-emergent adverse events
Time frame: Through Month 24
Incidence and severity of treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, CRS, ICANS, adverse events of special interest, and treatment- or procedure-related adverse events.
6 secondary outcomes
Proportion of Participants Achieving Response
Time frame: Through Month 24
Pharmacokinetics of C-CAR168 Utilizing Flow Cytometry
Time frame: Through Month 24
Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)
Time frame: Through Month 24
Proportion of Participants Progressed
Time frame: Through Month 24
Time to First Response
Time frame: Through Month 24
Duration of Response (DOR)
Time frame: Through 24 months
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 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made available to other researchers.
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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.
Yihong Yao, PhD study director
AbelZeta Inc.
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 C-CAR168 in people with Systemic Sclerosis (SSc) and Systemic Sclerosis, run by AbelZeta Inc. at 1 site in United States.
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 16 inclusion and 5 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 13 Oct 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 States. 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 Kirstin Liechty, Head of Clinical Operations, PhD (267-566-6081, kirstin.liechty@abelzeta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (time frame: Through Month 24). 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 13 Oct 2026.