CD19 CAR-T Therapy for Elderly Patients With B-cell Non-Hodgkin's Lymphoma

• Status: Not yet recruiting
• Trial end date: 2026-12-20
• Target enrollment: 0
• Participant gender: All

Summary

A Study of CD19 CAR-T Therapy for Elderly Patients With B-cell Non-Hodgkin's Lymphoma.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Yake Biotechnology Ltd.

Criteria

Inclusion Criteria:

1. Age no less than 60, no gender limit;

2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);

3. Newly diagnosed B-NHL, unwilling to receive first- or second-line chemotherapy, but willing to receive targeted drugs (such as CD20 monoclonal antibody，lenalidomide and Brutons tyrosine kinase inhibitor) as preconditioning regimens for CAR-T cell therapy;

4. At least one assessable tumor lesion per Lugano 2014 criteria

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. ECOG performance status 0 to 2;

10. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. 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. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

8. Other uncontrolled diseases that were not suitable for this trial;

9. Patients with HIV infection;

10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.