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Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis

L

Liangjing Lu

Status and phase

Enrolling
Phase 1

Conditions

Systemic Sclerosis

Treatments

Biological: Relma-cel

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06414135
JWCAR029029

Details and patient eligibility

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

6 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy 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:

    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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Relma-cel arm
Experimental group
Description:
All participants will receive Relma-cel once at different dose levels
Treatment:
Biological: Relma-cel

Trial contacts and locations

1

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Central trial contact

Liangjing Lu; medical JW

Data sourced from clinicaltrials.gov

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