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NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors | Clinical Trials | Clareo Health

UNKNOWNPHASE1

NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors

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

NCT04550663•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18, male \& female;
•2. 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);
•3. Patients who fail first-line treatment or are unwilling to receive first-line treatment;
•4. 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;
•5. The main organs function normally and meet the following requirements;
•Blood routine examination shall be in accordance with (no blood transfusion within 14 days) :
•1. HB≥90g/L
•2. ANC ≥1.5×10\^9/L
•3. PLT ≥75×10\^9/L
•serum biochemicals examination shall be in accordance with:
+11 more criteria

Exclusion Criteria

•1. Pregnant or lactating women, pregnancy test positive by blood or urine within 48 hours before immune cell transplantation;
•2. Patients who need to be treated with systemic steroid;
•3. Under following treatment conditions currently:
•1. during the other anti-tumor clinical observation period within 14 days before blood collection;
•2. patient has not recovered from acute side effects of the previous treatment;
•4. Receive radiotherapy within 4 weeks before enrollment;
•5. Patients who received any other cell therapy before;
•6. Transfection efficiency of lymphocytes of patients \< 5% in feasibility assessment screening stage, or T cell amplification efficiency \< 5 times；
•7. Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis;
•8. Patients with severe acute allergic reactions, or the attending doctor believes there is an unpredictable risk;
+2 more criteria

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Key Dates

Start Date

September 25, 2020

Primary Completion Date

September 25, 2022

Completion Date

March 25, 2023

Last Updated

September 23, 2020

Enrollment

ESTIMATED participants

Conditions

Solid TumorHepatocellular CarcinomaColorectal CancerGlioma

Interventions

KD-025 CAR-T cells

DRUG

Contacts

Baorui Liu, M.D

CONTACT

+025-83106666 ext 61331 baoruiliu@nju.edu.cn

Jie Shen, M.D

CONTACT

+025-83106666 shenjie2008nju@163.com

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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: September 23, 2020Data 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.

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NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors

Inclusion Criteria

Exclusion Criteria

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