US Zamto-cel Autoimmune Diseases (NCT06708845) | Clinical Trial Compass
Not Yet RecruitingPhase 1
US Zamto-cel Autoimmune Diseases
48 participantsStarted 2025-01
Plain-language summary
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Key Inclusion/Exclusion Criteria Across All Cohorts
Inclusion Criteria:
•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc)
Exclusion Criteria:
* Prior gene therapy treatment
* Active malignancy within past 5 years
* Significant active fungal or bacterial infection
* History or presence of CNS lupus or other CNS disease
* eGFR \< 45 mL/min/1.73 m\^2
* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).
Systemic Lupus Erythematosus-Non-renal Key Inclusion/Exclusion Criteria
Inclusion Criteria:
* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith
* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores
* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab
Exclusion Criteria:
* Subjects with neuropsychiatric SLE.
* Drug-induced SLE.
Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria
Inclusion Criteria:
* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith
* Confirmed LN diagnosis by kidney biopsy duri…
What they're measuring
1
The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Timeframe: From enrollment through study completion 12 months post zamto-cel infusion
2
The proportion of subjects with dose-limiting toxicities (DLTs) up to Day 28 and determination of recommended Phase 2 dose (RP2D)
Timeframe: From enrollment through Day 28 post zamto-cel infusion