Sponsor decision to discontinue development and pursue an alternative clinical development strategy
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.
Protocol Amendment History
3 changes
criticalTrial status changed: Not Yet Recruiting → Withdrawn2026-07-17
criticalReason stopped changed: — → Sponsor decision to discontinue development and pursue an alternative clinical development strategy2026-07-17