CD19 CAR-T therapy for B-cell non-Hodgkin's lymphoma

Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

This study is testing a new CAR-T cell therapy for people with B-cell non-Hodgkin's lymphoma who don't want to have standard chemotherapy, to see how safe and effective it is.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: CAR-T, rituximab, zanubrutinib
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04661020 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CD19 CAR-T cell therapy in patients with B-cell non-Hodgkin's lymphoma. It is a single-arm, open-label study conducted at a single center, enrolling 36 patients who have CD19+ non-Hodgkin's lymphoma and are unwilling to undergo standard chemotherapy. Participants will receive preconditioning regimens before the CAR-T cell therapy, and the primary focus is on assessing dose-related safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed CD19+ B-cell non-Hodgkin's lymphoma who are unwilling to receive standard chemotherapy.

Not a fit: Patients with active infections, severe liver or kidney dysfunction, or those with an estimated survival time of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with B-cell non-Hodgkin's lymphoma who do not respond to conventional therapies.

How similar studies have performed: Other studies utilizing CAR-T cell therapy for B-cell malignancies have shown promising results, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age no less than 18, no gender limit;
2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
3. Confirmed CD19 and CD20 postive expressions in lymphoma cells
4. ECOG score 0-2;
5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
8. Estimated survival time ≥ 3 months;
9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
4. Active infection of hepatitis B virus or hepatitis C virus;
5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ;
7. Other uncontrolled diseases that were not suitable for this trial;
8. Patients with HIV infection;
9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: He Huang, PhD

Conditions Large B-Cell Lymphoma; CD19; CAR-T