NCT06464861 Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
| NCT ID | NCT06464861 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Primary Mediastinal B-cell Lymphoma (PMBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2024-06-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, no gender limit; 2. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type: 1. Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ； 2. Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; 3. Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; 3. Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines; 4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists; 5. The expected survival period is ≥12 weeks; 6. The puncture section of the tumor tissue was positive for CD19 expression; 7. ECOG score 0-2 points; 8. Sufficient organ function reserve: 1. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); 2. Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min; 3. Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; 4. Glomerular filtration rate\>50Ml/min 5. Cardiac ejection fraction (EF) ≥50%; 6. Under natural indoor air environment, basic oxygen saturation\>92% 9. Allow a previous stem cell transplantation 10. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication; 11. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation; 12. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial 13. Two tests for the new coronavirus or swine flu virus are negative. Exclusion Criteria: 1. Allergic to any of the components of cell products; 2. History of other tumors; 3. Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment; 4. Had received gene therapy within the past 3 months; 5. Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted; 6. Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons; 7. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\'s cardiac function grading criteria; 8. Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia); 9. Subjects with a history of epilepsy or other central nervous system disorders; 10. Head-enhanced CT or MRI showing evidence of central nervous system lymphoma; 11. Lactating women who are unwilling to stop breastfeeding; 12. Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.
Contact & Investigator
Wenbin Wenbin, Professor
STUDY CHAIR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06464861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Mediastinal B-cell Lymphoma (PMBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06464861 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06464861 currently recruiting?
Yes, NCT06464861 is actively recruiting participants. Contact the research team at qianwb@zju.edu.cn for enrollment information.
Where is the NCT06464861 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06464861 clinical trial?
NCT06464861 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Wenbin Wenbin, Professor at Zhejiang University. The trial plans to enroll 52 participants.