One-center, Open-label, Single-arm Clinical Study of the Safety and Effectiveness of NKG2D CAR-T Cells Infusion in the Treatment of Relapsed/ Refractory NKG2DL+ Tumors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country10 target enrollmentSeptember 25, 2020

ConditionsSolid Tumor Hepatocellular Carcinoma Colorectal Cancer Glioma

InterventionsKD-025 CAR-T cells

DrugsKD-025 CAR-T cells

Overview

Phase: Phase 1
Intervention: KD-025 CAR-T cells
Conditions: Solid Tumor
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 10
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.

Detailed Description

In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be asked to continue to undergo long-term gene safety follow-up.

Registry

clinicaltrials.gov

Start Date

September 25, 2020

End Date

March 25, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsible Party

Principal Investigator

Baorui Liu

Professor of Medicine

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

Inclusion Criteria

•Age ≥18, male \& female;
•Patients with recurrent/refractory NKG2DL+ tumors diagnosis by pathological histology or cytology, focus on the inclusion of patients with hepatocellular carcinoma positive. (If recruit liver cancer patients, patients should with locally advanced or metastatic hepatocellular carcinoma (HCC), Barcelona clinic liver cancer (BCLC) staging system classification for B or C, for B, patients are not suitable for local treatment and/or surgery, or disease progression occurs after surgery and/or local treatment, or declined to surgery and/or local treatment);
•Patients who fail first-line treatment or are unwilling to receive first-line treatment;
•Disease progression occurred within 14 days before inclusion (RECIST criteria must be used as a basis for assessment of disease progression). According to RECIST V1.1, patients have at least one measurable lesion. Target lesions located within the field of previous therapeutic irradiation or within the area of local treatment (interventional or ablative treatment) are considered measurable if progress is confirmed;
•The main organs function normally and meet the following requirements;
•Blood routine examination shall be in accordance with (no blood transfusion within 14 days) :
•ANC ≥1.5×10\^9/L
•PLT ≥75×10\^9/L
•serum biochemicals examination shall be in accordance with:
•BIL \<1.5 upper normal limit (ULN)

Exclusion Criteria

•Pregnant or lactating women, pregnancy test positive by blood or urine within 48 hours before immune cell transplantation;
•Patients who need to be treated with systemic steroid;
•Under following treatment conditions currently:
•during the other anti-tumor clinical observation period within 14 days before blood collection;
•patient has not recovered from acute side effects of the previous treatment;
•Receive radiotherapy within 4 weeks before enrollment;
•Patients who received any other cell therapy before;
•Transfection efficiency of lymphocytes of patients \< 5% in feasibility assessment screening stage, or T cell amplification efficiency \< 5 times；
•Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis;
•Patients with severe acute allergic reactions, or the attending doctor believes there is an unpredictable risk;