Status and phase
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About
Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
voluntary to sign the ICF
aged between 18-65 years old (inclusive)
diagnosed with diffuse systemic sclerosis according to 2013 ACR Systemic Sclerosis Classification Criterion
meet the definitions of refractory/progressive as below:
refractory: non-respondent to or disease recurrence after remission with conventional therapies. Conventional therapies are defined as treated for more than 6 months with low dose steroids (≤ 15 mg prednisone equivalent), cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporin or biologics such as rituximab, belimumab, telitacicept, tocilizumab;
progressive: having below manifestations within 6 months
without systemic active infections within 2 weeks of leukapheresis, e.g., infectious pneumonia, tuberculosis
available vascular access for leukapheresis
major organ functions:
negative result of serum β-hCG measurement for women of childbearing potential at screening and within 48 hours of the first dose of lymphodepletion
Female subjects with childbearing potential or male subjects with partners of childbearing potential should adopt medically effective contraception or abstinence from enrollment to 2 years after the end of the study; female subjects with childbearing potential should have a negative serum hCG test within 7 days of enrollment and not in lactation
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Central trial contact
Liangjing Lu; medical JW
Data sourced from clinicaltrials.gov
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