Treatment of relapsed or refractory diffuse large B-cell lymphoma with JWCAR201

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm study evaluates the safety and efficacy of JWCAR201 in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study employs a two-stage dose escalation design, starting with an accelerated titration approach to determine the maximum tolerated dose (MTD) based on observed dose-limiting toxicities (DLTs). Patients will receive varying doses of CAR+ T-cells, and the study aims to assess the relationship between the dose and the probability of DLTs using a model-based approach. The study will provide insights into the therapeutic potential of JWCAR201 for this challenging patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18
2. Voluntarily willing to participate in the study and sign the written informed consent form
3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
4. 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)
5. At least one measurable lesion by CT or PET per Lugano criteria
6. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
7. Adequate organ functions
8. Adequate venous access for apheresis
9. Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion
10. 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 Criteria:

1. Primary central nervous system lymphoma
2. Another primary malignancy within 2 years
3. Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
4. With severe active deep venous thrombosis or pulmonary embolism within 3 months
5. Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months
6. Uncontrolled or active infection
7. Acute or chronic graft-versus-host disease (GvHD)
8. With severe cardiovascular diseases within 6 months
9. With severe clinically-significant central nervous system disorders within 6 months
10. Pregnant or lactating women
11. Not satisfying pre-defined wash-out period for apheresis
12. 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
13. Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Rong Tao, MD — Fudan University
• Study coordinator: Rong Tao, MD
• Email: rtao@shca.org.cn
• Phone: +8621-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.