Actively Recruiting
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
Led by Liangjing Lu · Updated on 2024-08-15
6
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
L
Liangjing Lu
Lead Sponsor
S
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to sign the informed consent form
- Aged between 18 and 65 years old (inclusive)
- Diagnosed with diffuse systemic sclerosis according to 2013 ACR Systemic Sclerosis Classification Criteria
- Have refractory or progressive disease as defined by non-response or recurrence after conventional therapies or recent worsening within 6 months
- No systemic active infections within 2 weeks before leukapheresis
- Have available vascular access for leukapheresis
- Meet major organ function requirements: renal function with creatinine clearance ≥ 50 ml/min; bone marrow function with ANC ≥ 1000/uL, lymphocyte count ≥ 100/uL, hemoglobin ≥ 90 g/L, platelet count ≥ 75 x 10^9/L; liver function with ALT and AST ≤ 3 times upper limit of normal, total bilirubin ≤ 2 times upper limit of normal (or ≤ 3 times with Gilbert syndrome); coagulation with INR ≤ 1.5 times upper limit of normal, PT ≤ 1.5 times upper limit of normal; cardiac function with left ventricular ejection fraction ≥ 55%
- Women of childbearing potential must have negative serum β-hCG test at screening and within 48 hours before lymphodepletion
- Female subjects with childbearing potential or male subjects with partners of childbearing potential must use effective contraception or abstinence from enrollment to 2 years after study end
- Female subjects with childbearing potential must have negative serum hCG test within 7 days of enrollment and not be lactating
You will not qualify if you...
- New York Heart Association class IV heart failure
- Forced vital capacity predicted less than 45% or diffusing capacity of the lungs for carbon monoxide predicted less than 40%
- Lung abnormalities on HRCT not caused by systemic sclerosis
- History of autologous stem cell transplantation
- Presence of renal crisis
- Other autoimmune diseases requiring systemic treatment
- History of severe drug allergy
- Congenital immunoglobulin deficiency
- Presence of malignant tumors except specific cancers disease-free for over 2 years
- Psychiatric diseases or severe cognitive dysfunction
- Within 5 half-life cycles of last investigational product administration
- Pregnant, breastfeeding, or planning pregnancy within one year
- Previous CAR-T or other gene-modified T cell therapies
- Conditions unsuitable for study enrollment per investigator judgment
- Use of live vaccines against infections within one month before screening
- Active tuberculosis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200001
Actively Recruiting
Research Team
L
Liangjing Lu
CONTACT
M
medical JW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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