A Phase 1 interventional study of NKG2D-based CAR T-cells in Hepatocellular Carcinoma, Glioblastoma and Medulloblastoma, sponsored by Jiujiang University Affiliated Hospital. Withdrawn at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Jiujiang University Affiliated Hospital · Phase 1, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
Browse Glioblastoma studies →This is the only study on the registry with Jiujiang University Affiliated Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main organs function normally and meet following requirements:
Routine blood index(No Blood transfusion within 14 days) 1)HB≥90g/L; 2)ANC≥1.5×109/L; 3)PLT≥75×109/L; Serum biochemicals index 1) BIL \<1.5 upper normal limit (ULN); 2) ALT and AST\<2.5×ULN; In the case of liver metastasis, ALT and AST\<5×ULN; 3) Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula); 4) ECOG physical condition score: 0-2
Exclusion criteria:
Detailed disease specific criteria exist and can be discussed with contacts listed below.
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
Biological: NKG2D-based CAR T-cells
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
Also known as: KD-025 CAR T-cells
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
The severe CRS post KD-025 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Time frame: 0 to 28 days post infusion
Copies numbers of CAR
Copies numbers of CAR in peripheral blood (PB)
Time frame: 1 year post infusion
overall survival (OS)
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Time frame: 2 years post infusion
Progress Free Survival (PFS)
Progress Free Survival after administration
Time frame: 2 years post infusion
Duration of response, (DoR)
Time frame: 2 years post infusion
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.