Universal CD19/BCMA CAR T-cell therapy for relapsed or refractory neurological autoimmune diseases
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases
This will test whether a single infusion of universal CD19/BCMA CAR T-cells given after chemotherapy helps adults with relapsed or refractory neurological autoimmune diseases who have CD19- or BCMA-positive B cells.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Huanhu Hospital Academic / other |
| Drugs / interventions | CAR T, cyclophosphamide, fludarabine |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06939166 on ClinicalTrials.gov |
What this trial studies
This open-label, single-site, dose-escalation study will enroll up to 12 adults with relapsed or refractory neurological autoimmune diseases (NMOSD, myasthenia gravis, multiple sclerosis, CIDP, or autoimmune encephalitis) who have CD19 or BCMA-positive B cells. Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of allogeneic (universal) CD19/BCMA CAR T-cells. Safety, tolerability, and early signs of clinical effect will be monitored closely with scheduled visits and laboratory testing. An interim analysis is planned when participants complete the 90-day visit after CAR T-cell infusion.
Who should consider this trial
Good fit: Ideal participants are adults (≥18 years) with relapsed or refractory NMOSD, myasthenia gravis, multiple sclerosis, CIDP, or autoimmune encephalitis who have detectable CD19 or BCMA-positive B cells in peripheral blood and can undergo lymphodepleting chemotherapy and follow-up.
Not a fit: Patients without detectable CD19 or BCMA B cells, those who cannot tolerate lymphodepletion or immunosuppression, pregnant or lactating individuals, or people with major uncontrolled comorbidities are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce or eliminate disease-causing B cells and produce durable remissions for people with treatment-refractory neurological autoimmune conditions.
How similar studies have performed: Autologous CD19-targeted CAR T-cells have shown promising results in small reports for some autoimmune diseases, but universal allogeneic CD19/BCMA CAR T-cell therapy is a newer approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood. * Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP). * Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating. * Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: * Subjects with a history of severe drug allergies or allergic tendencies. * History of malignancy within five years. * Subjects with insufficient cardiac function. * Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing. * Pregnant women or women planning to conceive.
Where this trial is running
Tianjin
- Tianjin Huanhu Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jialing Wu
- Email: wywjl2009@hotmail.com
- Phone: 86-18622271026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.