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NCT07523100
A Study on the Safety and Tolerability of Universal STAR-T Cell Therapy for Multiple Sclerosis.
Phase 1 trial testing Universal STAR-T Cell Injection in Multiple Sclerosis (MS) in 24 participants. Not yet recruiting.
1 April 2027
Quick facts
| Lead sponsor | Daishi Tian |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 7 April 2026 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Universal STAR-T Cell Injection
Conditions studied
- Multiple Sclerosis (MS) — all drugs for Multiple Sclerosis (MS) →
Sponsor
Daishi Tian — full company profile →
Who can join
Adults 18 to 65, any sex, with Multiple Sclerosis (MS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection. The primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body. This study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells). Expansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell. This study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07523100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Multiple Sclerosis (MS)
Currently open trials in the same condition.
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- NCT06270641 — Increasing Physical Activity for Adults With Multiple Sclerosis (MS) · NA · recruiting
- NCT06157086 — Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France · active not recruiting
Other Daishi Tian trials
Trials by the same sponsor.
- NCT07303790 — This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis · EARLY_PHASE1 · recruiting
- NCT07337785 — CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07086404 — GC012F Injection in Refractory Idiopathic Inflammatory Myopathy · EARLY_PHASE1 · recruiting
- NCT07058298 — GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103) · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07523100 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daishi Tian
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07523100.
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