A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Liangjing Lu
Lu_liangjing@163.com
86-13661472001
Backup
medical JW
Relma-celMedical@jwtherapeutics.com
+86 21 50464201
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2027-04
Participants
Target number of participants: 6
Treatments
Experimental: Relma-cel arm
All participants will receive Relma-cel once at different dose levels
Related Therapeutic Areas
Sponsors
Leads: Liangjing Lu
Collaborators: Shanghai Ming Ju Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov