Experimental CAR-T therapy targets stubborn autoimmune disease
NCT ID NCT07148791
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This Phase 2 trial tests a personalized cell therapy called anti-BCMA-CD19 CAR-T cells in 9 adults with IgG4-related disease that hasn't responded to standard treatments. Participants receive an infusion of their own modified immune cells after a short course of chemotherapy. The study aims to see if the therapy is safe and can reduce disease activity over 26 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-BCMA-CD19 CAR-T cells (a personalized immune cell therapy made from the patient's own blood cells, modified to target specific proteins)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat IgG4-related disease, potentially reducing symptoms and disease activity without long-term medication.
- What could go wrong
- This is a very early, small trial with only 9 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and nerve problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: To participate, subjects must meet all of the following criteria: 1. Aged 18 to 75 years, inclusive, regardless of sex. 2. Meet the 2019 ACR/EULAR classification criteria for IgG4-related disease. 3. Involvement of two or more important systems/sites (including but not limited to the pancreas, bile ducts, kidneys and dura mater). 4. Relapsed or refractory IgG4-RD: The disease either remains active after 3 months of glucocorticoid and/or rituximab therapy or relapses within 6 months post-treatment. 5. Important organ function meeting the following conditions: * Bone marrow: (i) neutrophil count ≥1×10\^9/L (excluding disease-related neutropenia); (ii) hemoglobin ≥60 g/L. * Hepatic function: ALT≤3×ULN (elevation caused by disease may be excluded); AST≤3×ULN (elevation caused by disease may be excluded); TBIL≤1.5×ULN (elevation caused by disease may be excluded). * Renal function: creatinine clearance (Cockcroft-Gault formula) ≥30 ml/min (excluding acute decline due to disease). * Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN * Cardiac function: stable hemodynamics. 6. Women of childbearing potential and male subjects with partners of childbearing potential must use medically accepted contraception or abstain during study treatment and for at least 12 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding. 7. Voluntary participation in this clinical study with signed informed consent and willingness to comply with study procedures and follow-up. 8. Patent superficial peripheral veins adequate for intravenous infusion. Exclusion Criteria: Subjects will be excluded if any of the following criteria are met: 1. History of severe drug allergy or allergic constitution. 2. Current or suspected uncontrollable or treatment-requiring fungal, bacterial, viral or other infections. 3. Central nervous system disease (excluding disease-related epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis). 4. Cardiac insufficiency that precludes participation. 5. Congenital immunoglobulin deficiency. 6. Congenital malformation or nutritional disorder causing severe organ impairment. 7. History of malignancy within the past five years. 8. End-stage renal failure. 9. Positive hepatitis B surface antigen and hepatitis B core antibody with HBV-DNA titers above the assay limit of detection; positive hepatitis C antibody with HCV-RNA positivity; positive human immunodeficiency virus antibody; positive syphilis serology. 10. Psychiatric disorders or severe cognitive impairment. 11. Participation in other clinical trials within three months before enrollment. 12. Receipt of any investigational drug within 12 weeks before screening or within five half-lives of the agent (whichever is longer). 13. Pregnant or intending to become pregnant. 14. Any other reason deemed by the investigator to preclude enrollment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell mediated autoimmune disorders are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Investigational drug AMG 335 offered to adults with IgG4-Related disease
- Can inhaled cell vesicles soothe damaged lungs in autoimmune disease?
- Can engineered immune cells tame a stubborn autoimmune disease?
- New drug aims to stop IgG4 disease relapses without Long-Term steroids
- Experimental CAR-T injection aims to tame autoimmune diseases
- 15-Year safety check for experimental cell therapy