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New treatment option for Systemic Sclerosis
Official title Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
ClinicalTrials.gov ID: NCT06414135
What this study is testing
What is Relma-cel?
Relma-cel is an investigational medicine, being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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 people with childbearing potential or male people with partners of childbearing potential should adopt medically effective contraception or abstinence from enrollment to 2 years after the end of the study; female...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.