Treatment of relapsed or refractory diffuse large B-cell lymphoma with JWCAR201
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
This study is testing a new treatment called JWCAR201 to see if it helps adults with hard-to-treat diffuse large B-cell lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06517004 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed DLBCL who have relapsed or are refractory to at least two prior treatment lines.
Not a fit: Patients who have not undergone prior treatment with anthracyclines and anti-CD20-targeted regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat diffuse large B-cell lymphoma.
How similar studies have performed: Other studies utilizing CAR-T therapy for DLBCL have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.