Loading clinical trials...

Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

NCT04887012•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteer to participate in this study and sign an informed consent form;
•2. Age 18-75 years old, no gender limit;
•3. 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;
•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;
+13 more criteria

Exclusion Criteria

•1. Those who have a history of allergies to any of the ingredients in cell products;
•2. History of other tumors
•3. Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
•4. Have received gene therapy in the past 3 months;
•5. Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
•6. Hepatitis B (HBsAg positive, but HBV-DNA \<103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including But not limited to people living with HIV;
•7. According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV.
•Impaired subjects;
•8. Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);
•9. Subjects with a history of epilepsy or other central nervous system diseases;
+4 more criteria

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

May 1, 2021

Primary Completion Date

May 1, 2022

Completion Date

May 1, 2024

Last Updated

May 14, 2021

Enrollment

ESTIMATED participants

Conditions

B-cell Non Hodgkin Lymphoma

Interventions

anti-CD19 CAR-NK

BIOLOGICAL

Contacts

Wenbin Qian

CONTACT

+8613605801032 qianwb@zju.edu.cn

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

NCT06365671

B-cell Non Hodgkin Lymphoma

View study

RECRUITINGPHASE1

Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL

NCT06707259

B-cell Non Hodgkin Lymphoma

View study

RECRUITINGPHASE1

Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

Inclusion Criteria

Exclusion Criteria

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL

Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

MargheRITA (Remote Intelligence for Therapeutic Adherence)

A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- NHL