An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Recruiting now · Phase 1

Conditions studied: Diffuse Large B Cell Lymphoma

In brief

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).

Key facts

Study ID

NCT06517004

Run by

Fudan University

People needed

9

Starts

2024-07-18

Expected to finish

2027-08-01

Last updated by the study team

2024-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Primary central nervous system lymphoma
• 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
• Treated with anti-coagulations (except for prophylaxis use) due to 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
• 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
• Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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