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Tests treatment safety and results for Autoimmune Diseases
Official title Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
ClinicalTrials.gov ID: NCT04561557
What this study is testing
What is CT103A cells?
CT103A cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female people aged 18-75 years (including 18 and 75 years);
- people with Relapsing/refractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:
- people must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind...
- people with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and...
- people with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN/PNS diagnostic criteria and...
You likely can't join if
- Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.
- History of autoimmune hemolytic disease.
- History of solid organ transplantation.
- Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior...
- Patients with Papovaviruses infection.
- Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with...
See the full eligibility criteria
Who can join
- Male or female people aged 18-75 years (including 18 and 75 years);
- people with Relapsing/refractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:
- people must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with...
- people with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of...
- people with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN/PNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one...
- people were diagnosed with IIM defined by 2017 European League against Rheumatism/American Rheumatology (EULAR/ACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN...
- All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on people.
- Enrolled people must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109/L (or normal lower limit set by the central lab of the...
- Blood oxygen saturation \> 91% in resting state.
- Echocardiography suggests LVEF≥ 50%.
- Expected life expectancy ≥ 12 weeks as assessed by the investigator.
- After signing the informed consent form, people and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding...
- people must provide written informed consent before the study begin.
What rules you out
- Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.
- History of autoimmune hemolytic disease.
- History of solid organ transplantation.
- Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.
- Patients with Papovaviruses infection.
- Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer...
- Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
- MG crisis was not effectively controlled within 2 weeks before enrollment.
- Known history of primary immunodeficiency (innate or acquired).
- Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA)...
- Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.
- Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.
- Any serious and/or uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator
- Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;
- History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
- Prone to allergies or history of serious allergy.
- Pregnant or lactating women.
- Patients with other conditions adjudicated by the investigator as unsuitable for enrollment. Criteria for lymphodepletion and CAR-T cells infusion: Before lymphocyte depletion and CAR-T cells infusion, patients are...
- Blood tests: neutrophil count \< 2 × 109/L, platelet count \< 50 × 10\^9/L;
- Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;
- Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous...
- Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.
- Cell infusion is delayed \> 7 days after lymphodepletion for any reason;
- Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.