Actively Recruiting
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Led by Fudan University · Updated on 2024-07-24
9
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
CONDITIONS
Official Title
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing to participate and sign informed consent
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with CD20-positive markers
- Previously treated with anthracyclines and anti-CD20 regimens, refractory or relapsed after at least 2 treatment lines or autologous stem-cell transplant
- At least one measurable lesion on CT or PET scan per Lugano criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Adequate venous access for apheresis
- Women of childbearing potential agree to use effective contraception until 1 year post-infusion
- Male patients without vasectomy who have sexual activity with women of childbearing potential agree to use barrier contraception until 1 year post-infusion
You will not qualify if you...
- Primary central nervous system lymphoma
- Another primary cancer within the past 2 years
- Active infections with hepatitis B, hepatitis C, HIV, or syphilis
- Severe active deep venous thrombosis or pulmonary embolism within 3 months
- Use of anticoagulants for severe deep venous thrombosis or pulmonary embolism within 3 months (except prophylaxis)
- Uncontrolled or active infection
- Acute or chronic graft-versus-host disease (GvHD)
- Severe cardiovascular disease within 6 months
- Severe clinically significant central nervous system disorders within 6 months
- Pregnant or breastfeeding women
- Not completed required wash-out period before apheresis
- Unable or unwilling to follow study protocol or judged inappropriate by investigator
- Previous treatment with genetically engineered modified T-cell therapy or other cell-gene therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
R
Rong Tao, MD
CONTACT
W
Wenhao Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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