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NCT07854483

PHASE1

A Phase 1b Study of C-CAR168 in Participants With Systemic Sclerosis (SSc)

Sponsor: AbelZeta Inc.

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-03

Completion Date

2030-03

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Systemic Sclerosis (SSc)Systemic Sclerosis Systemic Sclerosis (Scleroderma)Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria Systemic Sclerosis Pulmonary Systemic Sclerosis With Lung Involvement

Interventions

BIOLOGICAL

C-CAR168

Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion at a target dose of 1 × 10\^6 CAR-positive T cells/kg (maximum dose 100 × 10\^6 CAR-positive T cells).

Key Inclusion Criteria: 1. Able to sign and date the Informed Consent Form (ICF). 2. Female or male, aged 18-70 years (inclusive) with body weight ≥40 kg. 3. Have a clinical diagnosis of diffuse cutaneous SSc according to the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification. 4. Disease duration between the onset of the first non-Raynaud's sign/symptom and ICF signing shall be ≤ 6 years. 5. SSc Disease Activity meet all following criteria: 1. Modified Rodnan Skin Score (mRSS) ≥15. 2. Chest High Resolution Computed Tomography (HRCT) shows SSc related ground-glass opacities. 3. Percent predicted forced vital capacity (ppFVC)\<70% or precent predicted (diffusing capacity of the lungs for carbon monoxide) ppDLco\<70%. 6. Positivity for at least one SSc-specific autoantibodies: 1. anti-Scl70 antibody. 2. anti-RNA polymerase III antibody. 3. anti-centromere antibody. 4. anti-Th/To antibody. 5. and anti-U3RNP antibody. 7. 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. 8. Ability to taper steroids to protocol allowed doses Exclusion Criteria: 1. ppFVC\<45% or ppDLco \<40%. 2. 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. 3. Presence of clinically significant abnormalities on chest high-resolution computed tomography (HRCT) that are UNRELATED to SSc. 4. Cutaneous sclerosis that impedes venous access required for leukapheresis, lymphodepletion, C-CAR168 infusion, other study procedures and emergency rescue interventions.