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Not yet taking people in United StatesPhase 1

C-CAR168 CAR T-cell therapy for systemic sclerosis that has not responded to standard treatment

Tests C-CAR168 cell therapy in adults with systemic sclerosis not helped by standard treatment.

Key facts

Who runs it
AbelZeta Inc.
Where
Gilbert, United StatesSee the site
Trial code
Registry title
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy
Status
Not yet recruiting
Phase
Phase 1
People taking part
12 people, planned
Starts
Mar 2027
Expected to end
Mar 2030
Type of study
Interventional
Treatments tested
  • C-CAR168
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with diffuse systemic sclerosis (scleroderma) with lung involvement whose disease did not respond to standard treatments.

Age
18-70 years (inclusive), body weight at least 40 kg (88 lb).
Sex
Women and men can join.
Disease stage
Diffuse cutaneous systemic sclerosis, with the first non-Raynaud's sign or symptom no more than 6 years ago. Skin score (mRSS) of 15 or more, SSc-related ground-glass opacities on chest CT, and lung function (ppFVC or ppDLco) below 70%.
Earlier treatment
Did not respond to at least two earlier standard treatments, such as immunosuppressive drugs and/or a biologic, each taken for at least 6 months. Must be able to lower steroid doses to the amounts the study allows.
Biomarker or test result
Positive for at least one SSc-specific antibody: anti-Scl70, anti-RNA polymerase III, anti-centromere, anti-Th/To or anti-U3RNP.

Main reasons for not taking part

  • ppFVC below 45% or ppDLco below 40%
  • Severe pulmonary arterial hypertension (high pressure in the lung blood vessels)
  • Chest CT changes not caused by SSc
  • Skin hardening that blocks the venous access needed for the study procedures

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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; 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 take part

  • 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
  • ppFVC<45% or ppDLco <40%
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in United States

  • Gilbert, ArizonaHospital not named in the registryContact: Kirstin Liechty, Head of Clinical Operations, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • C-CAR168Treatment being tested

    Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
C-CAR168 CAR T-cell therapy for systemic sclerosis that has not responded to standard treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07854483, who can take part
Record updated
13 October 2026