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WithdrawnNCT04270461Updated Oct 22, 2020

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

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 Withdrawn at 1 site in China.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

Why this study was withdrawn
Study is withdrawn because of administrative reasons
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Hepatocellular Carcinoma
  • Glioblastoma
  • Medulloblastoma
  • Colon Cancer

Keywords

  • NKG2D-based CAR T-cells
  • solid tumors
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

Browse Glioblastoma studies →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.

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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalNKG2D-based CAR T-cells

    Autologous genetically modified anti-NKG2DLs CAR transduced T cells

    Also known as: KD-025 CAR T-cells

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What researchers measure

Primary outcomes

  1. 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

  2. Copies numbers of CAR

    Copies numbers of CAR in peripheral blood (PB)

    Time frame: 1 year post infusion

Secondary outcomes

  1. 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

  2. Progress Free Survival (PFS)

    Progress Free Survival after administration

    Time frame: 2 years post infusion

  3. Duration of response, (DoR)

    Time frame: 2 years post infusion

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Study locations

1 site
  • Affiliated hospital of jiujiang university
    Jiujiang, Jiangxi 332000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04270461
Lead sponsor
Jiujiang University Affiliated Hospital
Collaborators
KAEDI
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Mar 17, 2020
Primary completion
Oct 17, 2020
Completion
Oct 17, 2020
Last update
Oct 22, 2020

Study contacts

Changchun Cai
study director · Affiliated hospital of jiujiang university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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