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C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease

NCT06935474 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-03

No results posted yet for this study

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. 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.

Conditions

  • Lupus Nephritis (LN)

Interventions

BIOLOGICAL

C-CAR168

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.

Sponsors & Collaborators

  • AbelZeta Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Antonia · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-05-31
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935474 on ClinicalTrials.gov