Status:
RECRUITING
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lead Sponsor:
Fudan University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Detailed Description
This is an open-label, single-arm, investigator-initiated study (IIT) to evaluate the safety an JWCAR201 in adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). The study...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06517004
Start Date
July 18 2024
End Date
August 1 2027
Last Update
July 24 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032