Lupus Nephritis (LN)Phase 1/2NCT06935474
C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease
A Phase 1/2 study testing C-CAR168 in people with Lupus Nephritis (LN), run by AbelZeta Inc. at 1 site in United States.
Trial 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 diseases refractory to standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- C-CAR168
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jun 2030
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Phase 1/2 Study of an Autologous Anti-CD20/BCMA CAR T Cell Therapy (C-CAR168) for the Treatment of Autoimmune Disease Refractory to Standard Therapy
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 diseases refractory to standard treatments. The study includes both dose escalation and dose expansion phases, with participants grouped into condition-specific cohorts.
The purpose of this study is to:
Read more
- Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168.
- Determine the recommended Phase 2 dose of C-CAR168 in subjects with autoimmune disease refractory to standard treatment.
Participants will be asked to:
- Undergo screening to determine eligibility based on entry criteria.
- Taper steroid use before leukapheresis.
- Undergo leukapheresis for the manufacturing of C-CAR168.
- Temporarily discontinue immunosuppressive therapy at least 7 days prior to leukapheresis.
- Receive bridging therapy (steroids) if necessary to maintain disease stability during C-CAR168 manufacturing.
- Undergo lymphodepletion therapy with fludarabine and cyclophosphamide.
- Receive a single intravenous infusion of C-CAR168 at the assigned dose level on Day 0.
- Attend regular safety and efficacy assessments for up to 24 months post-infusion.
- Undergo dose-limiting toxicity evaluation during the first 28 days post-infusion (for those in the dose escalation phase).
- Follow withdrawal procedures if necessary, including a discharge visit within 14 days if their condition deteriorates, unacceptable toxicity occurs, they no longer meet criteria, or they choose to withdraw.
- Conditions
- Lupus Nephritis (LN)
- Being tested
- C-CAR168
- Keywords
- Autoimmune, Lupus Nepritis, Systemic Lupus Erythematosus, CAR-T, CD20, C-CAR168, BCMA
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR168Biological
This is a multi-center, Phase 1/2, open-label, dose-escalation and dose-expansion study evaluating C-CAR168 for the treatment of autoimmune diseases refractory to standard therapy. A traditional 3+3 design is used to identify the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) in disease-specific cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2: Dose Level 1 (DL1) | Experimental | Dose: 0.75 × 10⁶ CAR+ cells/kg Starting dose for escalation phase. First 3 subjects must be staggered by 28 days. Receives: Biological: C-CAR168 |
| Arm 3: Dose Level 2 (DL2) | Experimental | Dose: 1.5 × 10⁶ CAR+ cells/kg Second dose level in escalation phase. Subject enrollment staggered by 28 days. Receives: Biological: C-CAR168 |
| Arm 1: Dose Level -1 (DL-1) | Experimental | 0.5 × 10⁶ CAR+ cells/kg Optional dose level, administered only upon Safety Review Committee (SRC) recommendation. Receives: Biological: C-CAR168 |
| Arm 4: Dose Level 3 (DL3) | Experimental | Dose: 2.0 × 10⁶ CAR+ cells/kg Optional dose level pending SRC review and approval. Receives: Biological: C-CAR168 |
| Arm 5: Dose Expansion Cohort | Experimental | Dose: To be selected based on MTD/RD identified in escalation phase. 12-24 additional subjects will be treated at the selected dose level. No staggered dosing required. Receives: Biological: C-CAR168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events or Dose Limiting Toxicities
The number and severity of Adverse Events (AE) and Serious Adverse Events (SAE), including dose limiting toxicities (DLTs) will be recorded.
Measured: Up to 24 months
Secondary outcomes (12)
To evaluate the efficacy of C-CAR168
Proportion of subjects meeting the KDIGO 2024 Clinical Practice Guidelines' Definition of Remission, which includes complete response, primary efficacy renal response, or partial response.
Measured: Up to 24 months
To evaluate the efficacy of C-CAR168
Proportion of subjects achieving SLEDAI-2K response over time.
Measured: Up to 24 months
To evaluate the efficacy of C-CAR168
Proportion of subjects achieving British Isles Lupus Assessment Group (BILAG)(BILAG) response over time.
Measured: Up to 24 months
Renal Related Events
Record any renal related events during the study, including disease flare and the time to the event.
Measured: Up to 24 months
Time to Response
The number of days to response from the infusion of C-CAR0168 to the first recorded remission.
Measured: Up to 24 months
Corticosteroid use
The number of patients who achieved a low dose of steroids or no longer require.
Measured: Up to 24 months
To characterize the cellular kinetics of C-CAR168
Level of C-CAR168 positive cells in the blood.
Measured: Up to 24 months
To assess immunogenicity of C-CAR168
Presence of C-CAR168 antibodies.
Measured: Up to 24 months
To evaluate the efficacy of C-CAR168
Proportion of subjects whose for Physician Global Assessment (PGA) score does not worsen over time.
Measured: Up to 24 months
To evaluate the efficacy of C-CAR168
Proportion of subjects achieving a predefined score on the Visual Analog Scale (VAS) at specified time points.
Efficacy will be assessed by evaluating changes in pain intensity as perceived by subjects, using the Visual Analog Scale (VAS). Subjects will rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). This will provide a subjective measure of pain severity over the course of the study.
Measured: Up to 24 months
To assess changes for reported health-related quality of life, overall health status
To assess changes from baseline for Functional Assessment of Chronic Illness Therapy (FACIT).
The 13-item questionnaire will measure the level of fatigue and its impact on daily functioning. Higher scores reflect less fatigue and better overall energy levels.
Measured: Up to 24 months
To assess changes for reported health-related quality of life, overall health status
To assess changes from baseline for SF-36 (Short Form Health Survey). Efficacy will be assessed by evaluating changes in quality of life using the SF-36. Higher scores indicate better overall health and quality of life.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study startJul 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: Sponsor decision to discontinue development and pursue an alternative clinical development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study uses a 3+3 dose escalation design to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of C-CAR168. Subjects in each dose level will be enrolled sequentially with a minimum 28-day interval between infusions. Upon completion of dose escalation, 12-24 additional subjects may be enrolled in a dose expansion phase, pending Safety Review Committee (SRC) approval. No staggering is required during the expansion phase.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbelZeta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Antonia, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935474
- Sponsor's protocol ID
- ABZT-411
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Phase 1/2 Study of an Autologous Anti-CD20/BCMA CAR T Cell Therapy (C-CAR168) for the Treatment of Autoimmune Disease Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT06935474
- Acronym / sponsor ID
- ABZT-411
- Conditions
- Lupus Nephritis (LN)
- Keywords
- Autoimmune, Lupus Nepritis, Systemic Lupus Erythematosus, CAR-T, CD20, C-CAR168, BCMA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to discontinue development and pursue an alternative clinical development strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbelZeta Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 20 Apr 2025 (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 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 diseases refractory to standard treatments. The study includes both dose escalation and dose expansion phases, with participants grouped into condition-specific cohorts.
The purpose of this study is to:
- Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168.
- Determine the recommended Phase 2 dose of C-CAR168 in subjects with autoimmune disease refractory to standard treatment.
Participants will be asked to:
- Undergo screening to determine eligibility based on entry criteria.
- Taper steroid use before leukapheresis.
- Undergo leukapheresis for the manufacturing of C-CAR168.
- Temporarily discontinue immunosuppressive therapy at least 7 days prior to leukapheresis.
- Receive bridging therapy (steroids) if necessary to maintain disease stability during C-CAR168 manufacturing.
- Undergo lymphodepletion therapy with fludarabine and cyclophosphamide.
- Receive a single intravenous infusion of C-CAR168 at the assigned dose level on Day 0.
- Attend regular safety and efficacy assessments for up to 24 months post-infusion.
- Undergo dose-limiting toxicity evaluation during the first 28 days post-infusion (for those in the dose escalation phase).
- Follow withdrawal procedures if necessary, including a discharge visit within 14 days if their condition deteriorates, unacceptable toxicity occurs, they no longer meet criteria, or they choose to withdraw.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This study uses a 3+3 dose escalation design to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of C-CAR168. Subjects in each dose level will be enrolled sequentially with a minimum 28-day interval between infusions. Upon completion of dose escalation, 12-24 additional subjects may be enrolled in a dose expansion phase, pending Safety Review Committee (SRC) approval. No staggering is required during the expansion phase.
| Arm | Type | Receives |
|---|---|---|
| Arm 2: Dose Level 1 (DL1) | Experimental | Biological: C-CAR168Dose: 0.75 × 10⁶ CAR+ cells/kg Starting dose for escalation phase. First 3 subjects must be staggered by 28 days. |
| Arm 3: Dose Level 2 (DL2) | Experimental | Biological: C-CAR168Dose: 1.5 × 10⁶ CAR+ cells/kg Second dose level in escalation phase. Subject enrollment staggered by 28 days. |
| Arm 1: Dose Level -1 (DL-1) | Experimental | Biological: C-CAR1680.5 × 10⁶ CAR+ cells/kg Optional dose level, administered only upon Safety Review Committee (SRC) recommendation. |
| Arm 4: Dose Level 3 (DL3) | Experimental | Biological: C-CAR168Dose: 2.0 × 10⁶ CAR+ cells/kg Optional dose level pending SRC review and approval. |
| Arm 5: Dose Expansion Cohort | Experimental | Biological: C-CAR168Dose: To be selected based on MTD/RD identified in escalation phase. 12-24 additional subjects will be treated at the selected dose level. No staggered dosing required. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
Key exclusion criteria (23 listed)
- 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:
- 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.
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-CAR168This is a multi-center, Phase 1/2, open-label, dose-escalation and dose-expansion study evaluating C-CAR168 for the treatment of autoimmune diseases refractory to standard therapy. A traditional 3+3 design is used to identify the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) in disease-specific cohorts. | Biological | Arm 1: Dose Level -1 (DL-1), Arm 2: Dose Level 1 (DL1), Arm 3: Dose Level 2 (DL2), Arm 4: Dose Level 3 (DL3), Arm 5: Dose Expansion Cohort |
Primary outcome
Incidence of Adverse Events or Dose Limiting Toxicities
Time frame: Up to 24 months
The number and severity of Adverse Events (AE) and Serious Adverse Events (SAE), including dose limiting toxicities (DLTs) will be recorded.
12 secondary outcomes
To evaluate the efficacy of C-CAR168
Time frame: Up to 24 months
To evaluate the efficacy of C-CAR168
Time frame: Up to 24 months
To evaluate the efficacy of C-CAR168
Time frame: Up to 24 months
Renal Related Events
Time frame: Up to 24 months
Time to Response
Time frame: Up to 24 months
Corticosteroid use
Time frame: Up to 24 months
To characterize the cellular kinetics of C-CAR168
Time frame: Up to 24 months
To assess immunogenicity of C-CAR168
Time frame: Up to 24 months
To evaluate the efficacy of C-CAR168
Time frame: Up to 24 months
To evaluate the efficacy of C-CAR168
Time frame: Up to 24 months
To assess changes for reported health-related quality of life, overall health status
Time frame: Up to 24 months
To assess changes for reported health-related quality of life, overall health status
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 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. This study is not recruiting at the moment.
Scott Antonia principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing C-CAR168 in people with Lupus Nephritis (LN), 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 25 inclusion and 23 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: withdrawn, as of the sponsor's last update on 16 Jul 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events or Dose Limiting Toxicities (time frame: Up to 24 months). 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 16 Jul 2026.