RecruitingPhase 1NCT06517004

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

Sponsor

Fudan University

Enrollment

9 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria13

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