C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease

Part of paid clinical trials in Rockville, Maryland.

Sponsor
AbelZeta Inc.
Study ID
NCT06935474
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Lupus Nephritis (LN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • C-CAR168 — BIOLOGICAL
    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 Details

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: 1. Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168. 2. 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.

Key Dates

Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 2: Dose Level 1 (DL1)
    Dose: 0.75 × 10⁶ CAR+ cells/kg Starting dose for escalation phase. First 3 subjects must be staggered by 28 days.
  • Experimental: Arm 3: Dose Level 2 (DL2)
    Dose: 1.5 × 10⁶ CAR+ cells/kg Second dose level in escalation phase. Subject enrollment staggered by 28 days.
  • Experimental: Arm 1: Dose Level -1 (DL-1)
    0.5 × 10⁶ CAR+ cells/kg Optional dose level, administered only upon Safety Review Committee (SRC) recommendation.
  • Experimental: Arm 4: Dose Level 3 (DL3)
    Dose: 2.0 × 10⁶ CAR+ cells/kg Optional dose level pending SRC review and approval.
  • Experimental: Arm 5: Dose Expansion Cohort
    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.

Primary Outcome Measure

Incidence of Adverse Events or Dose Limiting Toxicities [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AbelZeta, Inc.RockvilleMaryland20850-

Find similar trials in Rockville, MD

By research site
AbelZeta, Inc.· Rockville, MD

Related Studies