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

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ClinicalTrials.gov Identifier: NCT04270461
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
KAEDI
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)
Estimated Enrollment : 10 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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

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:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04270461


Contacts
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Contact: Hui Xu 86+13337719185 huixu1989@163.com
Contact: Peifei Mei 86+18507926828 meipfei@163.com

Locations
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China, Jiangxi
Affiliated hospital of jiujiang university
Jiujiang, Jiangxi, China, 332000
Contact: Changchun Cai    86+13870257887    13870257887@163.com   
Contact: Hui Xu    86+13337719185    huixu1989@163.com   
Principal Investigator: Pengfei Mei         
Sub-Investigator: Jingjing Zhu         
Sponsors and Collaborators
Jiujiang University Affiliated Hospital
KAEDI
Investigators
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Study Director: Changchun Cai Affiliated hospital of jiujiang university
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Responsible Party: Jiujiang University Affiliated Hospital
ClinicalTrials.gov Identifier: NCT04270461    
Other Study ID Numbers: JiujiangUH
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: February 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
Glioblastoma
Medulloblastoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive