JWCAR201 Treatment Study for Returned or Unresponsive Large B-Cell Lymphoma
Tests JWCAR201 in adults whose diffuse large B-cell lymphoma returned or did not respond.
Plain-language title generated from the registry record
Registry title: An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT06517004
- Record updated
- 24 July 2024
- Original description
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).Read full original descriptionShow less
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
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).
Inclusion: Age ≥18; Voluntarily willing to participate in the study and sign the written informed consent form; Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive; Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT); At least one measurable lesion by CT or PET per Lugano criteria; Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1; Adequate organ functions; Adequate venous access for apheresis; Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion; Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion.
Exclusion: Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months; Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy; Another primary malignancy within 2 years; Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis; With severe active deep venous thrombosis or pulmonary embolism within 3 months; Uncontrolled or active infection; Acute or chronic graft-versus-host disease (GvHD); With severe cardiovascular diseases within 6 months; With severe clinically-significant central nervous system disorders within 6 months; Primary central nervous system lymphoma; Pregnant or lactating women; Not satisfying pre-defined wash-out period for apheresis; Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study.