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Hepatocellular CarcinomaPhase 1NCT04270461

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

A Phase 1 study testing NKG2D-based CAR T-cells in people with Hepatocellular Carcinoma and Glioblastoma, run by Jiujiang University Affiliated Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
NKG2D-based CAR T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
17 Mar 2020to 17 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men or women≥18 years old,
  • Patient with NKG2DL+ cell tumors confirmed by pathology and histology，
  • Fail or unwilling to receive first-line treatment,
  • Disease must be measurable according to the corresponding guidelines,
  • 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
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  • Expected survival time ≥3 months,
  • Patient with adequate bone marrow reserve, hepatic and renal functions,
  • No other uncontrolled diseases such as lung, kidney and liver infection before enrollment,
  • 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,
  • Patients voluntarily participated in this trial and sign the informed consent form,
  • Patients with compliance and expected to follow up the efficacy and adverse reactions as required by the protocol.

Who cannot join

  • Pregnant or lactating women,
  • Patients who need to use systemic steroids at the same time,
  • 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;
  • Receive radiotherapy within 4 weeks before enrollment,
  • Patients who received any other cell therapy before,
  • Patients with unqualified T cell amplification efficiency,
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  • Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis,
  • Patients with severe acute allergic reactions,
  • Patients who have received other cell therapies,
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated hospital of jiujiang university

    Jiujiang, Jiangxi, 332000

Other trials in China

About this study

Official title: A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors

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.

Being tested
NKG2D-based CAR T-cells
Keywords
NKG2D-based CAR T-cells, solid tumors
Medical subject headings
Carcinoma, Hepatocellular, Glioblastoma, Medulloblastoma, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKG2D-based CAR T-cellsBiological

    Also called KD-025 CAR T-cells

    Autologous genetically modified anti-NKG2DLs CAR transduced T cells

Study groups in NCT04270461
Study groupRoleWhat they receive
ArmsExperimentalNKG2D-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
Receives: Biological: NKG2D-based CAR T-cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 to 28 days post infusion

  2. Copies numbers of CAR

    Copies numbers of CAR in peripheral blood (PB)

    Measured: 1 year post infusion

Secondary outcomes (3)

  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

    Measured: 2 years post infusion

  2. Progress Free Survival (PFS)

    Progress Free Survival after administration

    Measured: 2 years post infusion

  3. Duration of response, (DoR)

    Measured: 2 years post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start17 Mar 2020
  3. Primary completion17 Oct 2020
  4. Study completion17 Oct 2020

Why it stopped: Study is withdrawn because of administrative reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270461
Sponsor's protocol ID
JiujiangUH
Status last verified
Oct 2020
First submitted
10 Feb 2020
Last updated
22 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKG2D-based CAR T-cells in people with Hepatocellular Carcinoma and Glioblastoma, run by Jiujiang University Affiliated Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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