NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors

Phase 1

Withdrawn

• Conditions: Medulloblastoma; Colon Cancer; Glioblastoma; Hepatocellular Carcinoma
• Interventions: Biological: NKG2D-based CAR T-cells

• Registration Number: NCT04270461
• Lead Sponsor: Jiujiang University Affiliated Hospital

Brief Summary

The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.

Detailed Description

The preclinical study clarified that NKG2D-based CAR-T cells showed strong cytotoxicity against NKG2DL+ cell lines in vitro as well as a therapeutic effect against NKG2DL+ cell xenografts in vivo. In addition, the data also demonstrated the safety of NKG2D-based CAR-T therapy. NKG2D-based CAR-T represent a potentially effective and safety therapeutic approach for patient with relapsed/refractory NKG2DL+ solid tumors. In this trial, the investigators researched the safety of administering NKG2D-based CAR-T which generated with CD8 hinge region and transmembrane region, 4-1BB costimulatory region and CD3 zeta region. The investigators also assessed that disease response was determined within the context of a phase I trial.

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-03-17
• Status Verified: 2020-10
• Primary Completion: 2020-10-17
• Study Completion: 2020-10-17
• Last Update Submitted: 2020-10-18
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arms	NKG2D-based CAR T-cells	NKG2D-based CAR T-cells Injection; Dosage:1-10x10\^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. or hepatic portal artery injection over 20-30 minutes Frequency: total one time

Primary Outcome Measures

Name	Time	Method
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.	0 to 28 days post infusion	The severe CRS post KD-025 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Copies numbers of CAR	1 year post infusion	Copies numbers of CAR in peripheral blood (PB)

Secondary Outcome Measures

Name	Time	Method
Duration of response, (DoR)	2 years post infusion
overall survival (OS)	2 years post infusion	For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Progress Free Survival (PFS)	2 years post infusion	Progress Free Survival after administration

Trial Locations

Locations (1)

Affiliated hospital of jiujiang university; 🇨🇳 Jiujiang, Jiangxi, China