Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
ConditionGraves' Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
Graves' disease is an autoimmune thyroid disorder in which autoantibodies against the thyroid-stimulating hormone receptor (TRAb) lead to excessive thyroid hormone production and systemic complications, as well as thyroid eye disease and pretibial myxedema in some cases. Patients with refractory Graves' disease often fail to achieve durable remission despite prolonged antithyroid medication.
This study aims to evaluate the safety and efficacy of RD06-05, an allogeneic dual CD19/BCMA CAR-T therapy, in participants with refractory Graves' disease, and will provide preliminary evidence on whether dual-targeting CAR-T therapy can induce sustained remission of refractory Graves' disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Refractory Graves' disease, defined as meeting at least one of the following: a) Continuous treatment with antithyroid drugs (ATDs) for ≥3 years without achieving criteria for drug discontinuation. b) Meeting criteria for drug discontinuation but experiencing ≥2 relapses after withdrawal.
Positive serum TRAb.
Willing to voluntarily participate in this clinical study, able to sign informed consent, and compliant with follow-up requirements.
Disqualifiers
History of severe drug allergies or allergic constitution.
Presence or suspected presence of uncontrolled or active infections (including bacterial, fungal, viral, or other pathogens) requiring systemic or intravenous treatment.
Presence of central nervous system disorders (including epilepsy, psychosis, cerebrovascular accident, encephalitis, CNS vasculitis, etc).
Presence of clinically significant heart diseases (e.g., angina pectoris, myocardial infarction, heart failure, severe arrhythmias, etc).
Trial design
Design model
Single group
Treatments tested in this trial
allogenic anti-CD19/BCMA CAR-T
Biological/VaccineParticipants will receive a single infusion of allogenic anti-CD19/BCMA CAR-T (RD06-05).
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (AEs)
Time frame
From baseline to 12 months after infusion of CAR-T cells2
Remission of Graves' disease
Proportion of remission will be calculated throughout 12 months after infusion of CAR-T cells. Remission is defined as euthyroid status without anti-thyroid medication.
Time frame
From baseline to 12 months after infusion of CAR-T cellsSecondary outcomes
1
Proportion of participants with ≥50% reduction of anti-thyrotropin receptor antibody (TRAb)
Percentage of participants achieving a ≥50% reduction of TRAb throughout 12 months after infusion of CAR-T, as compared with baseline.
Time frame
From baseline to 12 months after infusion of CAR-T cells2
Proportion of participants with ≥50% reduction of thyroid stimulating immunoglobulin (TSI)
Percentage of participants achieving a ≥50% reduction of TSI throughout 12 months after infusion of CAR-T, as compared with baseline.
Time frame
From baseline to 12 months after infusion of CAR-T cells3
Change of TRAb levels compared to baseline
TRAb levels will be measured from baseline to 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cells4
Change of TSI levels compared to baseline
TSI levels will be measured from baseline to 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cellsOther outcomes
1
BCR repertoire dynamics (Exploratory)
High-throughput sequencing of B-cell receptor (BCR) repertoires
Time frame
From baseline to 12 months after infusion2
TCR repertoire dynamics (Exploratory)
High-throughput sequencing of T-cell receptor (TCR) repertoires
Time frame
From baseline to 12 months after infusionSponsors and contacts
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Source ClinicalTrials.gov