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New treatment option for Primary Mediastinal B-cell Lymphoma (PMBCL)
Official title Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
ClinicalTrials.gov ID: NCT06464861
What this study is testing
What is CD19-CAR-NK/T?
CD19-CAR-NK/T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary mediastinal b-cell lymphoma (pmbcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or...
- 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;
You likely can't join if
- Allergic to any of the components of cell products;
- History of other tumors;
- 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;
- Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics...
- Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and...
See the full eligibility criteria
- 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...
- 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...
- 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 people 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.
- Allergic to any of the components of cell products;
- History of other tumors;
- 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;
- 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...
- people with Grade III or IV cardiac dysfunction according to the New York Heart Association\'s cardiac function grading criteria;
- 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);
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.