A Phase 1/2 interventional study of BAFF-R CART in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder and Myasthenia Gravis, sponsored by Tianjin Medical University General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Tianjin Medical University General Hospital · Phase 1/2, Interventional, and Basic science
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.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's planned enrollment of 27 is below the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Assessed by the investigator as having a neuroimmune disease;
Refractory neuroimmune diseases were defined as:
2. Male study participants must agree to use during the treatment period for 1 year after receiving study treatment, and sperm donation is prohibited throughout the study period;
3. In the case of females with , need to agree to use contraception during the treatment period and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to first CART treatment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: CART cells therapy，Dose level 1: 0.5 × 10\^6 CART cells/Kg The tolerability and safety of BAFF-R CART cells will be assessed in an initial dose of 0.5×10\^6 CART cells/Kg and three subjects will be enrolled firstly. Experimental: CART cells therapy，Dose level 2: 1 × 10\^6 CART cells/Kg If neither DLT nor efficacy is shown in the first three subjects, the dose of CART cells will be increased to 1 × 10\^6 CART cells/kg to assess DLT. Experimental: CART cells therapy，Dose level 3: 2 × 10\^6 CART cells/Kg If DLT occurs in two subjects, whether to test the safety and efficacy in 2 × 10\^6 CART cells/kg group will be determined by the investigator based on the initial data of efficacy, PK and PD.
Drug: BAFF-R CART
Biological: BAFF-R CART cells Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture BAFF-R CART cells, during which cyclophosphamide will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with BAFF-R CART cells by intravenous (IV) infusion. The initial dose of 0.5×10\^6 CART cells/kg will be infused on day 0. Drug: Cyclophosphamide and fludarabine Subjects will receive one 3-day cycle of lymphodepletion starting 4 days prior to BAFF-R CART cells infusion on Day 0. Subjects will be given IV infusion of cyclophosphamide 250 mg/m2/day on day -5, -4 and -3, and fludarabine 30 mg/m2 over 30 minutes administered immediately after cyclophosphamide.
Types and incidence of dose-limiting toxicity (DLT) after BAFF-R CART cells infusion
To evaluate the DLT occurred within 3 months after BAFF-R CART cells infusion.
Time frame: Up to 3 months post BAFF-R CART cells infusion
Incidence and severity of AEs, including changes in vital signs, physical examination, laboratory parameters, Electrocardiograms and Echocardiograms.
To evaluate the AEs occurred within 2 years after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
PD-Soluble BAFF
The changes of concentration of soluble BAFF in the peripheral blood after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
PD-Pathogenic antibody
The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid.
Time frame: Up to 2 years post BAFF-R CART cells infusion
PD-Nfl（MS）
The changes of peripheral blood Neurofilament Light chain (NfL) concentration in patients with MS.
Time frame: Up to 2 years post BAFF-R CART cells infusion
PK-VCN
The number of BAFF-R CAR gene copies (VCN, copies/μg DNA) in peripheral blood and cerebrospinal fluid after administration.
Time frame: Up to 15 years post BAFF-R CART cells infusion
PK-BAFF-R CAR-T cells
The concentration of BAFF-R CAR T cells (cells/mL) in peripheral blood after administration was detected by flow cytometry.
Time frame: Up to 2 years post BAFF-R CART cells infusion
NMOSD: the number of attacks
The number of attacks divided by observed year after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
NMOSD: Accumulated total active MRI lesions
the number of accumulate total active MRI lesions after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
NMOSD: Expanded Disability Status Scale (EDSS) score
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Time frame: Up to 2 years post BAFF-R CART cells infusion
NMOSD: Modified Rankin Scale
Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6.
Time frame: Up to 2 years post BAFF-R CART cells infusion
NMOSD: Visual acuity
Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters. Higher score indicates better vision.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MG: Quantitative Myasthenia Gravis Score (QMG)
The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Time frame: Up to 2 years post BAFF-R CART cells infusion
MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score
The MG-ADL is an eight-question survey of symptom severity, with each response graded from 0 (normal) to 3 (most severe). Two questions concern ocular, three oropharyngeal, one respiratory, and two extremity functions. Cumulative MG-ADL scores range from 0 to 24.
Time frame: Up to 2 years post BAFF-R CART cells infusion
CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score
The INCAT score comprises two parts, the arm score and the leg score. Based on a patient's level of impairment in their arms and legs, each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10.
Time frame: Up to 2 years post BAFF-R CART cells infusion
CIDP: Medical Research Council (MRC) muscle function Score
The MRC score system for testing and grading of muscle function aims to provide a standardized and objective way to assess muscle function. It ranges from 0 to 5.
Time frame: Up to 2 years post BAFF-R CART cells infusion
CIDP: Assess changes in nerve conduction test results
Including motor nerve distal latency, proximal latency, compound muscle motor potential (CMAP), motor nerve conduction velocity, sensory nerve conduction velocity, sural nerve potential.
Time frame: Up to 2 years post BAFF-R CART cells infusion
IMNM: Manual Muscle Testing (MMT) Score
For MMT score, 16 muscle groups/ motions will be tested (not individual muscles). 14 of these are tested bilaterally.
Time frame: Up to 2 years post BAFF-R CART cells infusion
IMNM: Assess the changes in serum creatine kinase levels in patients with IMNM before and after treatment.
If the creatine kinase level drops to twice the upper limit of normal or below, it is defined as effective, and the effective rate is calculated.
Time frame: Up to 2 years post BAFF-R CART cells infusion
IMNM: Muscle MRI
Calculating the hyperintensity of muscle MRI T2/STIR sequence in patients with IMNM.
Time frame: Up to 2 years post BAFF-R CART cells infusion
36-item Short Form Generic Health Survey (SF-36) score
SF-36 will used to understand the health related quality-of -life of the subjects after BAFF-R CART cells infusion. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Time frame: Up to 2 years post BAFF-R CART cells infusion
EuroQol-five dimensions (EQ-SD) score
Health status is measured with the EuroQuality of Life Five Dimensions (EQ-5D) after BAFF-R CART cells infusion, which includes five dimensions and is used to evaluate the quality of life of sepsis survivors. They are mobility, self-care, usual activities, discomfort or pain and depression or anxiety. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value.
Time frame: Up to 2 years post BAFF-R CART cells infusion
Visual analogue scale (VAS) pain score
usual visual analog scale (VAS) of pain is used to evaluate pain after BAFF-R CART cells infusion (line from 0: no pain to 10:worst pain).
Time frame: Up to 2 years post BAFF-R CART cells infusion
Annual hospitalization rates
The number of In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Time frame: Up to 2 years post BAFF-R CART cells infusion
Cytokines release after BAFF-R CART cells infusion
Changes of concentration( pg/mL) of cytokines ( such as ferritin, CRP, IL-6 and procalcitonin) will be analyzed after Changes of concentration( pg/mL) of cytokines ( such as ferritin, CRP, IL-6 and procalcitonin) will be analyzed after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
Immunogenicity of BAFF-R CART cells
Anti-drug antibodies (ADA) against CAR on BAFF-R CART cells will be analyzed after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
Detection of RCL
Levels of replication competent lentivirus (RCL) will be monitored after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
Profiling of cell subtypes
Changes in cells in infused CART products, blood and CSF (including proportion of CD3+ T cells, CD3+CD4+ T cells and CD3+CD8+ T cells, ratio of CD4+ T/CD8+T, and single-cell sequencing) will be analyzed after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Annualized Relapse Rate (ARR)
Annualized relapse rate (ARR): Number of MS relapses divided by observed year after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Time to first relapse
Time from BAFF-R CART cells infusion to the first relapse of MS.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Number of T1 Gadolinium (Gd)
The changes of enhancing Lesions as detected by brain Magnetic Resonance Imaging (MRI).
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Annualized rate of T2 lesions
Annualized rate of T2 lesions：Number of New, and/or Enlarging T2 Hyperintense Lesions as detected by MRI divided by observed year after BAFF-R CART cells infusion.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Percent Change in T2 lesions volume
The percent change of T2 lesions volume as detected by MRI from the baseline.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Change in EDSS
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS).
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: Percent of NEDA-3
The no evidence of disease activity-3 (NEDA-3), defined as no relapse, no disability worsening, and no MRI activity.
Time frame: Up to 2 years post BAFF-R CART cells infusion
MS: 3-month CDP
Time to onset of 3-month CDP as assessed by EDSS score.
Time frame: Up to 3 months post BAFF-R CART cells infusion
MS: 6-month CDP
Time to onset of 6-month CDP as assessed by EDSS score.
Time frame: Up to 6 months post BAFF-R CART cells infusion
MS: Patient Reported Outcomes (PRO)
Including Fatigue Symptoms and Impacts Questionnaire -Relapsing Multiple Sclerosis (FSIQ-RMS), General Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire (PHQ-9), Health Utilities Index (HUI-III), Multiple Sclerosis Impact Scale (MSIS-29).
Time frame: Up to 2 years post BAFF-R CART cells infusion
Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →
Tianjin Medical University General Hospital