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Tests treatment safety and results for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official title Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
ClinicalTrials.gov ID: NCT07022197
What this study is testing
What is BAFF-R CART?
BAFF-R CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyradiculoneuropathy.
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
- 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).
- Phase 2: a mid-size study of how well it works
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 60
You may be able to join if
- 1\. Assessed by the investigator as having a refractory neuroimmune disease; Refractory neuroimmune diseases were defined as:
- Poor symptom control on at least three immunosuppressive agents for more than one year;
- Clinical evidence of at least two relapses within 12 months or three relapses within 24 months and one relapse within 12 months prior to screening...
You likely can't join if
- Any medical or psychiatric condition that, in the opinion of the investigator, may jeopardize the study participant or affect the study participant's...
- A history of drug or alcohol abuse within the 12 months prior to baseline, or any condition that in the opinion of the investigator is associated...
- Women who are breastfeeding or pregnant, or who plan to become pregnant at any time during the 12-month time period following treatment with CART, or...
- Study participants with a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) or serious infection (resulting in...
- The study participant has received a live attenuated vaccination within 8 weeks prior to baseline; or is scheduled to receive a live vaccination...
- Study participants who have received prior treatment with rituximab within 6 months prior to baseline;
See the full eligibility criteria
- 1\. Assessed by the investigator as having a refractory neuroimmune disease; Refractory neuroimmune diseases were defined as:
- Poor symptom control on at least three immunosuppressive agents for more than one year;
- Clinical evidence of at least two relapses within 12 months or three relapses within 24 months and one relapse within 12 months prior to screening. 2\. Male study participants must agree to use contraception during the...
- Any medical or psychiatric condition that, in the opinion of the investigator, may jeopardize the study participant or affect the study participant's ability to participate in this study;
- A history of drug or alcohol abuse within the 12 months prior to baseline, or any condition that in the opinion of the investigator is associated with poor adherence;
- Women who are breastfeeding or pregnant, or who plan to become pregnant at any time during the 12-month time period following treatment with CART, or a history of spontaneous or induced abortion within 4 weeks prior to...
- Study participants with a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) or serious infection (resulting in hospitalization or requiring antibiotic therapy) within 4 weeks prior to baseline;
- The study participant has received a live attenuated vaccination within 8 weeks prior to baseline; or is scheduled to receive a live vaccination (including COVID-19 vaccine) within 8 weeks after treatment;
- Study participants who have received prior treatment with rituximab within 6 months prior to baseline;
- Study participants had received tolizumab, eculizumab within 3 months prior to baseline;
- Study participants who have received intravenous human immunoglobulin, plasma exchange, undergone immunotherapy within 4 weeks prior to baseline;
- Known concomitant serious underlying diseases, such as hepatic and renal impairment, hematologic disorders, previous severe cardiovascular disease, severe hypertension, diabetes mellitus, poor control of blood pressure...
- Comorbid mental illness, suicidal ideation (affirmative answer (yes) to question 4 or question 5 of the Colombian Suicide Severity Rating Scale (C-SSRS) indicating a suicide attempt within the last 6 months);
- Any of the following laboratory abnormalities during the screening period (a repeat measurement may be taken during the screening period prior to randomization to confirm results); (1) Elevated liver enzymes: aspartate...
- Presence of a history of tuberculosis infection, high risk of acquired tuberculosis infection;
- known immunodeficiency diseases, including human immunodeficiency virus (HIV) infection;
- Viral hepatitis B surface antigen (HBsAg) positivity during the screening period;
- Receiving blood transfusion therapy 4 weeks prior to baseline or during the screening period;
- Any other condition that the investigator deems inappropriate for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.