Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma

NCT06464861 | Recruiting Phase 1

• 1 other identifier: 2024 (0673)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Mediastinal B-cell Lymphoma (PMBCL); Mantle Cell Lymphoma (MCL); Diffuse Large B Cell Lymphoma( DLBCL)

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicity (DLTs)

  To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

  Up to 28 days

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 2 years

• Progression free survival (PFS)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Complete response rate (CR)

  Up to 2 years

• Partial response rate (PR)

  Up to 2 years

Study Arms (1)

CD19-CAR-NK/T

EXPERIMENTAL

All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10\^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10\^6/kg

Biological: CD19-CAR-NK/T

Interventions

CD19-CAR-NK/T BIOLOGICAL

Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T

CD19-CAR-NK/T

Eligibility Criteria

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

You may qualify 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 (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

You may not qualify 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, 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;
• 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);
• 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.

Sponsors & Collaborators

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

Study Sites (1)

the Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse

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; Lymphoma, B-Cell

Study Officials

• Wenbin Wenbin, Professor

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Wenbin Qian, Professor

CONTACT

+8613605801032; qianwb@zju.edu.cn

Hui Liu, Professor

CONTACT

13819198629; sylen@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: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 7, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)