RecruitingPhase 1NCT06414135
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis
Sponsor
Liangjing Lu
Enrollment
6 participants
Start Date
Jun 12, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria18
- 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
- mRSS increases by >= 3
- FVC decreases by > 10% or FVC decreases by > 5% and DLCO decreases by > 15%
- without systemic active infections within 2 weeks of leukapheresis, e.g., infectious pneumonia, tuberculosis
- available vascular access for leukapheresis
- major organ functions:
- Renal function: CrCl ≥50 ml/min (Cockcroft/Gault equation)
- Bone marrow function: ANC ≥ 1000/uL, absolute lymphocyte count ≥100/uL, Hb ≥90 g/L, Platelet count ≥75 x 10\^9/L. Blood transfusion and infusion of growth factors within 7 days of eligibility assessment are not allowed.
- Liver function: ALT ≤ 3 x ULN, AST ≤ 3 x ULN, total bilirubin ≤ 2 x ULN (in case of Gilbert syndrome, total bilirubin ≤ 3 x ULN)
- Coagulation: INR ≤ 1.5 x ULN, PT ≤1.5 x ULN
- Cardiac function: LVEF ≥ 55%
- 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 Criteria16
- NYHA class IV
- FVC predicted < 45% or DLCO predicted < 40%
- abnormalities on HRCT not attributable to systemic sclerosis
- history of autologous stem cell transplantation
- with manifestations of renal crisis
- with other autoimmune comorbidities that need systemic treatment
- with a history of severe drug allergy
- with congenital immunoglobulin deficiency
- with malignant tumors, except for nonmelanoma skin cancer, in situ cervical cancer, bladder cancer, breast cancer which has been disease free for more than 2 years
- with psychiatric diseases or severe cognition dysfunctions
- within 5 half-life cycles of the last administration of an investigational product
- pregnant, lactation or plan to be pregnant within one year
- a history of CAR-T therapy or other gene-modified T cell targeted therapies
- other conditions that are not suitable for enrollment of the study in the judgement of the investigator
- the use of any live vaccines against infections within one month of the screening
- with any manifestations of active tuberculosis at screening
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Interventions
BIOLOGICALRelma-cel
All participants will receive Relma-cel once at different dose levels: 25×10\^6 CAR+ T cells、50×10\^6 CAR+ T cells、75×10\^6 CAR+ T cells
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06414135
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