Tests two CD19 immune cell treatments in adults with returning B cell lymphoma
Tests two CD19 immune cell treatments, one after another, in adults with lymphoma.
Plain-language title generated from the registry record
Registry title: Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06464861, who can take part
Where in China
- The Second Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT06464861
- Record updated
- 7 February 2025
- Original description
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphomaRead full original descriptionShow less
Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma
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
Inclusion: Age 18-75 years old, no gender limit; 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:; 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 ；; Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines; At least one measurable lesion with the longest diameter ≥ 1.5 cm exists; The expected survival period is ≥12 weeks; The puncture section of the tumor tissue was positive for CD19 expression; ECOG score 0-2 points; Sufficient organ function reserve:; Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min; Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; Glomerular filtration rate\>50Ml/min; Cardiac ejection fraction (EF) ≥50%; Under natural indoor air environment, basic oxygen saturation\>92%; Allow a previous stem cell transplantation; 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; Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation; Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial; Two tests for the new coronavirus or swine flu virus are negative.
Exclusion: Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment; Had received gene therapy within the past 3 months; 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); Allergic to any of the components of cell products; History of other tumors; Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted; 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; Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\'s cardiac function grading criteria; Subjects with a history of epilepsy or other central nervous system disorders; Head-enhanced CT or MRI showing evidence of central nervous system lymphoma; Lactating women who are unwilling to stop breastfeeding; Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.