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New treatment option for Refractory or Relapsed B-cell Non-Hodgkin Lymphoma
Official title Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05842707
What this study is testing
What is dualCAR-NK19/70 cell?
dualCAR-NK19/70 cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory or relapsed b-cell non-hodgkin lymphoma.
Also referred to as CAR-NK cell.
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 find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.
- Phase 2: a mid-size study of how well it works
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
- Voluntarily participate in the study and sign the informed consent;
- Age 18-75, male and female;
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), primary mediastinal B-cell lymphoma (PMBCL)...
- There was at least one measurable lesion with the longest diameter ≥ 1.5cm;
- Estimated life expectancy of more than 12 weeks other than primary disease;
You likely can't join if
- Allergic to any of the components of cell products;
- Previous or concurrent of other type of maligant tumors;
- Acute GvHD or generalized chronic GvHD with grade II-IV (Glucksberg standard) after previous autologous hematopoietic stem cell transplantation...
- Known history of systemic gene therapy within the prior 3 months;
- Active systemic fungal, viral, or bacterial infection (except for simple urinary tract infections and bacterial pharyngitis), however, Preventive...
- Known history of infection with hepatitis B (HBsAg positive, but HBV-DNA\<1000 is not excluded) or hepatitis C virus (including virus carriers)...
See the full eligibility criteria
- Voluntarily participate in the study and sign the informed consent;
- Age 18-75, male and female;
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), and other Indolent B-cell NHL transforming...
- There was at least one measurable lesion with the longest diameter ≥ 1.5cm;
- Estimated life expectancy of more than 12 weeks other than primary disease;
- Previously confirmed diagnosis as CD19+ or CD70+ B-NHL.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
- Adequate reserve of organ function: （A） Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤2.5 times the Upper Limit of Normal (ULN) for age; （B） A creatinine clearance (as estimated either by a...
- Once previous autologous hematopoietic stem cell transplantation (auto-HSCT) is allowed;
- For systemic therapy(Such as systemic chemotherapy, systemic radiotherapy and immunotherapy), at least 3 weeks，for Targeted drug therapy alone，at least 2 weeks，must have elapsed at the time of cell infusion;
- Either having failed or Relapsed after CAR-T therapy at 3 months of assessment;
- people of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study. Women of childbearing potential must have...
- The viral load of severe coronavirus disease 2019 (COVID-19) is undetectable per quantitative PCR and/or nucleic acid testing for two tests.
- Allergic to any of the components of cell products;
- Previous or concurrent of other type of maligant tumors;
- Acute GvHD or generalized chronic GvHD with grade II-IV (Glucksberg standard) after previous autologous hematopoietic stem cell transplantation (auto-HSCT); Or receiving of anti-GVHD therapy;
- Known history of systemic gene therapy within the prior 3 months;
- Active systemic fungal, viral, or bacterial infection (except for simple urinary tract infections and bacterial pharyngitis), however, Preventive treatment is permitted;
- Known history of infection with hepatitis B (HBsAg positive, but HBV-DNA\<1000 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases...
- Class III or IV heart failure as defined by the New York Heart Association;
- Persisting toxicities (\>grade 1, except for clinically non-significant toxicities such as alopecia, fatigue, and anorexia) due to prior trerapy;
- Known history of active seizures or presence of seizure activities or other central nervous system disease;
- Have evidence of central nervous system lymphoma(CNS lymphoma) on CT or MRI;
- Breast-feeding woman;
- Any circumstances that possibly increase the risk of people or interfere with study results, which judged by investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, 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.