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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04270461
Recruitment Status : Withdrawn (Study is withdrawn because of administrative reasons)
First Posted : February 17, 2020
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Glioblastoma Medulloblastoma Colon Cancer Biological: NKG2D-based CAR T-cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors
Actual Study Start Date : March 17, 2020
Actual Primary Completion Date : October 17, 2020
Actual Study Completion Date : October 17, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arms
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
Other Name: KD-025 CAR T-cells

Primary Outcome Measures :
  1. Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability. [ Time Frame: 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.

  2. Copies numbers of CAR [ Time Frame: 1 year post infusion ]
    Copies numbers of CAR in peripheral blood (PB)

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 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

  2. Progress Free Survival (PFS) [ Time Frame: 2 years post infusion ]
    Progress Free Survival after administration

  3. Duration of response, (DoR) [ Time Frame: 2 years post infusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  1. Men or women≥18 years old,
  2. Patient with NKG2DL+ cell tumors confirmed by pathology and histology,
  3. Fail or unwilling to receive first-line treatment,
  4. Disease must be measurable according to the corresponding guidelines,
  5. 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

  6. Expected survival time ≥3 months,
  7. Patient with adequate bone marrow reserve, hepatic and renal functions,
  8. No other uncontrolled diseases such as lung, kidney and liver infection before enrollment,
  9. Women of child-bearing age must undergo a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dose; men should agree to contraception during the observation period and within 8 weeks of the last dose,
  10. Patients voluntarily participated in this trial and sign the informed consent form,
  11. Patients with compliance and expected to follow up the efficacy and adverse reactions as required by the protocol.

Exclusion criteria:

  1. Pregnant or lactating women,
  2. Patients who need to use systemic steroids at the same time,
  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. Patients with unqualified T cell amplification efficiency,
  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,
  9. Patients who have received other cell therapies,
  10. Other serious conditions that may limit patient's participation in the study.

Detailed disease specific criteria exist and can be discussed with contacts listed below.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04270461

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China, Jiangxi
Affiliated hospital of jiujiang university
Jiujiang, Jiangxi, China, 332000
Sponsors and Collaborators
Jiujiang University Affiliated Hospital
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Study Director: Changchun Cai Affiliated hospital of jiujiang university
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Responsible Party: Jiujiang University Affiliated Hospital Identifier: NCT04270461    
Other Study ID Numbers: JiujiangUH
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiujiang University Affiliated Hospital:
NKG2D-based CAR T-cells
solid tumors
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive