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

NCT04887012 | Unknown Phase 1

• 1 other identifier: IR2021002168
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLTs)

  To evaluate the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma

  Up to 28 days

• The overall response rate(ORR)

  To determine the anti-tumor effectivity of CAR-NK019

  Up to 2 years

Secondary Outcomes (4)

• Overall survival (OS)

  Up to 2 years

• progression free survival (PFS)

  Up to 2 years

• Pharmacokinetics of CAR positive cells

  Up to 2 years

• Pharmacokinetics of CAR-NK cells

  Up to 2 years

Study Arms (1)

CAR-NK019

EXPERIMENTAL

All subjects were intravenously administrated with CAR-NK019

Biological: anti-CD19 CAR-NK

Interventions

anti-CD19 CAR-NK BIOLOGICAL

lentiviral vector-transducted HLA haploidentical NK cells to express anti-CD19 CAR

Also known as: CAR-NK019

CAR-NK019

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this study and sign an informed consent form;
• 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;

You may not qualify if:

• Those who have a history of allergies to any of the ingredients in cell products;
• History of other tumors
• Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
• Have received gene therapy in the past 3 months;
• Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
• According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV.
• Impaired subjects;
• 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);
• Subjects with a history of epilepsy or other central nervous system diseases;
• Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
• Have received any other drugs that target CD19;
• Women who are breastfeeding and unwilling to stop breastfeeding;
• Any other situation that the investigator believes may increase the risk of the subject or interfere with the results of the test.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Wenbin Qian

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Qian

CONTACT

+8613605801032; qianwb@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 14, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2024
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)