The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Administered according to package insert
Administered according to package insert
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
ORR at 3 month
Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);
Time frame: 3 months
CRR at 3 month
Complete response rate in subjects at 3 month
Time frame: 3 months
Duration of response (DOR)
Time from first response(PR or CR) to disease progression or death from any cause.
Time frame: up to 2 years after Relmacabtagene Autoleucel infusion
Duration of complete remission (DoCR)
Time from complete response (CR) to disease progression or death from any cause.
Time frame: up to 2 years after Relmacabtagene Autoleucel infusion
Duration of partial remission (DoPR)
Time from partial response (PR) to disease progression or death from any cause.
Time frame: up to 2 years after Relmacabtagene Autoleucel infusion
Time to response (TTR)
Time from JWCAR029 infusion to first documentation of CR or PR
Time frame: up to 2 years after Relmacabtagene Autoleucel infusion
Progression-Free Survival (PFS)
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
Time frame: up to 2 years after Relmacabtagene Autoleucel infusion
Overall Survival (OS)
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Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality, China
Institute of Hematology&Hospital of Blood Disease CAMS
Tianjin, Tianjin Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
...and 3 more locations
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Time frame: up to 2 year after Relmacabtagene Autoleucel infusion
Adverse events (AEs)
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Time frame: up to 2 year after Relmacabtagene Autoleucel infusion
Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel
Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood
Time frame: up to 1 year after Relmacabtagene Autoleucel infusion
Pharmacokinetic (PK)- Tmax of Relmacabtagene Autoleucel
Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood
Time frame: up to 1 year after Relmacabtagene Autoleucel infusion
Pharmacokinetic (PK)- AUC of Relmacabtagene Autoleucel
Area under the concentration vs time curve of Relmacabtagene Autoleucel
Time frame: up to 1 year after Relmacabtagene Autoleucel infusion
The concentration of Car-T cell
The concentration of Car-T cell in peripheral blood
Time frame: up to 1 year after Relmacabtagene Autoleucel infusion