Status:
NOT_YET_RECRUITING
C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease
Lead Sponsor:
AbelZeta Inc.
Conditions:
Lupus Nephritis (LN)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This multi-center, open-label, Phase 1/2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20/BCMA CAR-T therapy, in patients with autoimmune ...
Eligibility Criteria
Inclusion
- Informed Consent: Voluntary signed consent required.
- Age \& Gender: Males and females, 18-70 years old.
- Diagnosis: Clinical diagnosis of SLE per EULAR/ACR criteria for at least 6 months.
- Lupus Nephritis (LN): Biopsy-confirmed active proliferative LN (Class III/IV ± V) within the past 12 months.
- Refractory Disease:
- Treated with at least two immunosuppressants for ≥8 weeks.
- Stable but active disease despite standard therapy (steroids, IS, monoclonal antibodies).
- Steroid dose ≤30 mg/day (if applicable).
- Disease Activity at Screening:
- SLE without LN: SLEDAI-2K ≥8 and 1 BILAG A or 2 BILAG B scores.
- LN Patients: Proteinuria ≥1.0 g/day or UPCR ≥1.0 g/g.
- Autoantibody Status:
- o Positive ANA (≥1:80), anti-dsDNA (≥30 IU/mL), and/or anti-Smith antibody.
- Infection Status: No active infection within 2 weeks before leukapheresis.
- Life Expectancy: Greater than 6 months.
- Adequate Organ Function:
- Bone Marrow: ANC ≥1.0×10⁹/L, ALC ≥0.5×10⁹/L, Hb ≥80 g/L, PLT ≥75×10⁹/L.
- Coagulation: INR/APTT ≤1.5×ULN.
- Cardiac: LVEF ≥45% by ECHO/MUGA.
- Pulmonary: SpO₂ ≥92% on room air.
- Liver: ALT/AST ≤2.5×ULN, total bilirubin \<2.0 mg/dL.
- Renal: Creatinine clearance ≥40 mL/min (Cockcroft-Gault).
- Pregnancy \& Contraception:
- Women of childbearing potential must have a negative pregnancy test at screening.
- Both male and female participants must use highly effective contraception for 1 year post-treatment.
Exclusion
- Any other concomitant diseases requiring long term systemic steroids (oral or intravenously) treatment that may confound the interpretation of study results or have interference with background steroid tapering for the subjects.
- Any of the following:
- Positive for Hepatitis B surface antigen (HBsAg)/core antibody (HBcAb)/e antibody (HBeAb)/e antigen (HBeAg).
- Positive for Hepatitis C Virus (HCV) antibodies.
- Positive for Human Immunodeficiency Virus (HIV) antibodies.
- Positive for syphilis antigen or antibody.
- Have an uncontrolled active infection.
- History of major organ transplantation (such as heart, lung, liver, kidney) or history of bone marrow/hematopoietic stem cell transplantation.
- History of any of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening.
- History of ≥ Grade 2 bleeding within the past 30 days.
- Received a live vaccine within 4 weeks prior to signing the ICF.
- Received any of the following treatments:
- Prednisone treatment of ≥ 100 mg/d or equivalent corticosteroid therapy for ≥14 days within the previous 8 weeks.
- Receive plasma exchange, plasma separation, hemodialysis, or intravenous injection of immunoglobulin (IVIG) within 14 days prior to leukapheresis.
- Use of any other investigational clinical study drug within 28 days prior to leukapheresis. However, if the subject is not responsive to the treatment or have progressed and at least 3 half-lives have passed before the leukapheresis, he/she could be enrolled.
- Previously received any CAR-T cell products or other genetically modified T cell therapies.
- Rituximab/ocrelizumab/obinutuzumab within 6 months prior to screening
- Pregnant or breastfeeding women.
- History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia or cerebellar disease or other severe neuropsychiatric syndromes.
- History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated DVT is allowed)
- Diagnosed with malignant tumors within 5 years prior to signing the ICF, with the following exceptions: non-melanoma skin cancer that has been treated with radical therapy, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely excised breast carcinoma in situ.
- Poor compliance, unwilling or unable to adhere to the study protocol based on the investigator's assessment.
- Allergies to fludarabine, cyclophosphamide and/or known allergies to excipients of C-CAR168 cell product.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06935474
Start Date
January 1 2026
End Date
December 1 2029
Last Update
September 18 2025
Active Locations (1)
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1
AbelZeta, Inc.
Rockville, Maryland, United States, 20850