BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
ConditionInflammatory Myopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsoriCell Gene Therapeutics
About this trial
This single-arm, open-label, phase I trial evaluates the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with refractory Idiopathic inflammatory myopathy (IIM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 (age ≥18 years at first symptom onset), gender not limited;
Refractory IIM: At least one round of high-dose corticosteroid therapy and/or intravenous immunoglobulin, and at least two immunosuppressants (including but not limited to cyclophosphamide, mycophenolate mofetil, tacrolimus, cyclosporine, and azathioprine) have been used in adequate doses for more than 6 months;
At the time of enrollment, participants must be receiving background medication at a stable dose, defined as: receiving background therapy with one oral glucocorticoid and/or one immunosuppressant at a stable dose for ≥ 12 weeks;
MMT-8 score ≤141 (out of 150);
Disqualifiers
During the screening period, individuals with active viral, bacterial, or other infections requiring systemic treatment are excluded.
The presence of a serious, poorly controlled comorbidity that the investigator considers clinically significant, such as (but not limited to) neurological, cardiovascular, renal, hepatic, endocrine, or gastrointestinal disorders;
The estimated glomerular filtration rate (eGFR) using the MDRD formula is <40 ml/min/1.73m² ; [eGFR = 186 × (age) - 0.203 × SCr - 1.154 (mg/dl), for women, the result is multiplied by 0.742].
Study participants with total bilirubin >1.5 times the upper limit of normal (no specific restrictions are made for liver enzymes because inflammatory myopathy can cause elevated ALT/AST).
Trial design
Design model
Sequential
Treatments tested in this trial
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR-T
Biological/VaccineAnti-BCMA, Anti-CD19 Compound CAR-T cells
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single Arm Biologic InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Adverse Events (AEs) after ICG318 CAR-T infusion.
Number of participants with AEs, Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), and Dose Limiting Toxicities (DLTs).
Time frame
Starting day 0 and up to 2 years after ICG318 CAR-T infusion.Secondary outcomes
1
Determine the recommended phase 2 dose (RP2D) regimen.
The protocol is based on cohort schema with dose escalation from 1×10\^6/kg.
Time frame
Starting day 0 and assessed 2 years after ICG318 CAR-T infusion.2
The proportion of subjects who achieved drug-free remission.
Time frame
At 6 months (M), 12M, 24M after ICG318 CAR-T infusion.3
Basic Metabolic Panel
Sodium, Chloride, Potassium, Bicarbonate, BUN, Creatinine, and Glucose levels
Time frame
Days 1-7, 10, 14, 21, and 28, Months 2, 3, 6, 9, 12, 18, 24 post-ICG318 CAR-T4
Coagulation studies
PT/INR and aPTT
Time frame
Days 1-7, 10, 14, 21, and 28, Months 2, 3, 6, 9, 12, 18, 24 post-ICG318 CAR-TSponsors and contacts
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Source ClinicalTrials.gov