CAR-T cell therapy for systemic sclerosis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of Relmacabtagene Autoleucel (Relma-cel), a CAR-T cell therapy targeting CD19, in patients with early diffuse systemic sclerosis. Participants will undergo leukapheresis to collect T cells, followed by lymphodepleting chemotherapy and administration of Relma-cel at varying dose levels. The study aims to determine the optimal dosing and assess the treatment's impact on disease progression and symptoms. It is a Phase 1 interventional trial focusing on patients who have not responded to conventional therapies.

Why it matters

Who can join: the full rules

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:

  1. 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;
  2. progressive: having below manifestations within 6 months

     1. mRSS increases by \>= 3
     2. 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:

  1. Renal function: CrCl ≥50 ml/min (Cockcroft/Gault equation)
  2. 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.
  3. 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)
  4. Coagulation: INR ≤ 1.5 x ULN, PT ≤1.5 x ULN
  5. 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 Criteria:

* 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

Where it's running

• Renji Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Liangjing Lu
• Email: Lu_liangjing@163.com
• Phone: 86-13661472001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.