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

NCT04550663 | Unknown Phase 1

• 1 other identifier: 2020-172-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Hepatocellular Carcinoma; Colorectal Cancer; Glioma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  Incidence of dose-limiting toxicities

  90 days post infusion

• The occurrence of AEs and SAEs during the study treatment

  An adverse event is any undesirable experience associated with the use of a medical product in a patient

  0 to 28 days post infusion

Secondary Outcomes (3)

• Objective remission rate(ORR)

  1 year post infusion

• Progression free survival(PFS)

  2 year post infusion

• Overall survival (OS)

  2 years post infusion

Study Arms (1)

KD-025 CAR-T cells

EXPERIMENTAL

NKG2D-based CAR-T cells infusion

Drug: KD-025 CAR-T cells

Interventions

KD-025 CAR-T cells DRUG

Autologous genetically modified anti-NKG2DLs CAR transduced T cells

KD-025 CAR-T cells

Eligibility Criteria

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

You may qualify if:

• Age ≥18, male \& female;
• Patients who fail first-line treatment or are unwilling to receive first-line treatment;
• The main organs function normally and meet the following requirements;
• Blood routine examination shall be in accordance with (no blood transfusion within 14 days) :
• HB≥90g/L
• 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)
• ALT and AST\<2.5×ULN; In the case of liver metastasis, ALT and AST\<5×ULN
• Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min(Cockcroft-Gault formula)；
• ECOG physical condition score: 0-1;
• Expected survival time ≥3 months;
• No other uncontrollable benign diseases such as lung, kidney, liver infection before enrollment;
• Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days of enrollment and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration; men should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and within 8 weeks after the last administration;

You may not qualify if:

• 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;
• Patients who have received other cell therapies;
• Other serious conditions that may limit patient's participation in the study.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• KAEDI: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Central Study Contacts

Baorui Liu, M.D

CONTACT

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

Jie Shen, M.D

CONTACT

+025-83106666; shenjie2008nju@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: September 25, 2020
• Primary Completion: September 25, 2022
• Study Completion: March 25, 2023
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)