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NCT07022197
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
Phase 1, PHASE2 trial testing BAFF-R CART in Chronic Inflammatory Demyelinating Polyradiculoneuropathy in 27 participants. Currently enrolling.
30 December 2027
Quick facts
| Lead sponsor | Tianjin Medical University General Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 27 |
| Start date | 10 April 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- BAFF-R CART — full drug profile →
Conditions studied
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy — all drugs for Chronic Inflammatory Demyelinating Polyradiculoneuropathy →
- NMO Spectrum Disorder — all drugs for NMO Spectrum Disorder →
- Myasthenia Gravis — all drugs for Myasthenia Gravis →
- Idiopathic Inflammatory Myopathies — all drugs for Idiopathic Inflammatory Myopathies →
Sponsor
Tianjin Medical University General Hospital
Who can join
Adults 18 to 60, any sex, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy or NMO Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a phase Ib/IIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
CAR T-Cell Immunotherapy in Neuroautoimmune Diseases: Focus on the Central Nervous System
Demetriou F, Anagnostouli M. · · 2026
Verify or expand the search:
- PubMed search for NCT07022197
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Currently open trials in the same condition.
- NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP · Phase 3 · recruiting
- NCT06615622 — Our Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic · recruiting
- NCT06290128 — A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy ( · Phase 3 · recruiting
- NCT04561557 — Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous Sys · EARLY_PHASE1 · recruiting
Other Tianjin Medical University General Hospital trials
Trials by the same sponsor.
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- NCT07018375 — The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Th · Phase 4 · not yet recruiting
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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 NCT07022197 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University General Hospital
- Last refreshed: 15 June 2025
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/NCT07022197.
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