This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagene Autoleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last Relmacabtagene Autoleucel administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Treatment-related adverse events (AEs)
Type, Proportion, and Severity
Time frame: 2 years
Recommended dose of JWCAR029
Recommended dose of JWCAR029
Time frame: 28 days after JWCAR029 infusion
Best Objective response (BOR) rate
iwCLL2018
Time frame: 3 months
Best Complete response (CR) rate
iwCLL2018
Time frame: 3 months
Objective response rate (ORR)
iwCLL2018
Time frame: 3 months
Complete response rate (CRR)
iwCLL2018
Time frame: 3 months
MRD-negative response rate
Proportion of subjects who achieve MRD-negative OR and CR
Time frame: 3 months
Progression free survival (PFS)
iwCLL2018
Time frame: 2 years
Overall survival (OS)
iwCLL2018
Time frame: 2 years
Duration of response
iwCLL2018
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Time frame: 2 years
Pharmacokinetics- Maximum concentration (Cmax)
Flow cytometry and qPCR
Time frame: 2 years
Pharmacokinetics- Time of the maximum concentration (Tmax)
Flow cytometry and qPCR
Time frame: 2 years
Pharmacokinetics- area under the curve
Flow cytometry and qPCR
Time frame: 2 years
Serum cytokines associated with CRS
IL-6, IL-8, TGF-β1, TNF-α, etc.
Time frame: 2 years