NCT06517004RecruitingPhase 1
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Source: ClinicalTrials.gov · Last updated 24 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 18 Jul 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06517004
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 18 Jul 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.