Solid TumorPhase 1NCT04550663
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
A Phase 1 study testing KD-025 CAR-T cells in people with Solid Tumor and Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness 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 years and older
- Conditions the study is for
- Solid Tumor, Hepatocellular Carcinoma, Colorectal Cancer
- What is being tested?
- KD-025 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2020to 25 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, male \& female;
- Patients with recurrent/refractory NKG2DL+ tumors diagnosis by pathological histology or cytology, focus on the inclusion of patients with hepatocellular carcinoma positive. (If recruit liver cancer patients, patients should with locally advanced or metastatic hepatocellular carcinoma (HCC), Barcelona clinic liver cancer (BCLC) staging system classification for B or C, for B, patients are not suitable for local treatment and/or surgery, or disease progression occurs after surgery and/or local treatment, or declined to surgery and/or local treatment);
- Patients who fail first-line treatment or are unwilling to receive first-line treatment;
- Disease progression occurred within 14 days before inclusion (RECIST criteria must be used as a basis for assessment of disease progression). According to RECIST V1.1, patients have at least one measurable lesion. Target lesions located within the field of previous therapeutic irradiation or within the area of local treatment (interventional or ablative treatment) are considered measurable if progress is confirmed;
- The main organs function normally and meet the following requirements;
- Blood routine examination shall be in accordance with (no blood transfusion within 14 days) :
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- HB≥90g/L
- ANC ≥1.5×10^9/L
- PLT ≥75×10^9/L
- serum biochemicals examination shall be in accordance with:
- BIL <1.5 upper normal limit (ULN)
- ALT and AST<2.5×ULN; In the case of liver metastasis, ALT and AST<5×ULN
- Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min(Cockcroft-Gault formula)；
- ECOG physical condition score: 0-1;
- Expected survival time ≥3 months;
- Cardiac function well before inclusion, no myocardial infarction attack occurred within half a year, and hypertension and other coronary heart disease were under control at present;
- No other uncontrollable benign diseases such as lung, kidney, liver infection before enrollment;
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days of enrollment and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration; men should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and within 8 weeks after the last administration;
- 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；
- CAR-T cells amplify successfully to the expected number.
Who cannot join
- Pregnant or lactating women, pregnancy test positive by blood or urine within 48 hours before immune cell transplantation;
- Patients who need to be treated with systemic steroid;
- Under following treatment conditions currently:
- during the other anti-tumor clinical observation period within 14 days before blood collection;
- patient has not recovered from acute side effects of the previous treatment;
- Receive radiotherapy within 4 weeks before enrollment;
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- Patients who received any other cell therapy before;
- Transfection efficiency of lymphocytes of patients < 5% in feasibility assessment screening stage, or T cell amplification efficiency < 5 times；
- Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis;
- Patients with severe acute allergic reactions, or the attending doctor believes there is an unpredictable risk;
- Patients who have received other cell therapies;
- Other serious conditions that may limit patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
About this study
Official title: One-center, Open-label, Single-arm Clinical Study of the Safety and Effectiveness of NKG2D CAR-T Cells Infusion in the Treatment of Relapsed/ Refractory NKG2DL+ Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
Read the detailed description
In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be asked to continue to undergo long-term gene safety follow-up.
- Conditions
- Solid Tumor, Hepatocellular Carcinoma, Colorectal Cancer, Glioma
- Being tested
- KD-025 CAR-T cells
- Medical subject headings
- Carcinoma, Hepatocellular, Colorectal Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD-025 CAR-T cellsDrug
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
| Study group | Role | What they receive |
|---|---|---|
| KD-025 CAR-T cells | Experimental | NKG2D-based CAR-T cells infusion Receives: Drug: KD-025 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Incidence of dose-limiting toxicities
Measured: 90 days post infusion
The occurrence of AEs and SAEs during the study treatment
An adverse event is any undesirable experience associated with the use of a medical product in a patient
Measured: 0 to 28 days post infusion
Secondary outcomes (3)
Objective remission rate(ORR)
Imaging assessment of tumor remission
Measured: 1 year post infusion
Progression free survival(PFS)
Progress Free Survival after administration
Measured: 2 year post infusion
Overall survival (OS)
overall survival refers to the period from being included in the test group to death caused by any reason
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.
- First posted16 Sep 2020
- Study start25 Sep 2020 (estimated)
- Primary completion25 Sep 2022 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- KAEDI
- Responsible party
- Principal investigator, Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550663
- Sponsor's protocol ID
- 2020-172-01
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-center, Open-label, Single-arm Clinical Study of the Safety and Effectiveness of NKG2D CAR-T Cells Infusion in the Treatment of Relapsed/ Refractory NKG2DL+ Tumors
- ClinicalTrials.gov ID
- NCT04550663
- Acronym / sponsor ID
- 2020-172-01
- Conditions
- Solid Tumor, Hepatocellular Carcinoma, Colorectal Cancer, Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- KAEDI
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
Detailed description
In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be asked to continue to undergo long-term gene safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KD-025 CAR-T cells | Experimental | Drug: KD-025 CAR-T cellsNKG2D-based CAR-T cells infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥18, male \& female;
- Patients with recurrent/refractory NKG2DL+ tumors diagnosis by pathological histology or cytology, focus on the inclusion of patients with hepatocellular carcinoma positive. (If recruit liver cancer patients, patients should with locally advanced or metastatic hepatocellular carcinoma (HCC), Barcelona clinic liver cancer (BCLC) staging system classification for B or C, for B, patients are not suitable for local treatment and/or surgery, or disease progression occurs after surgery and/or local treatment, or declined to surgery and/or local treatment);
- Patients who fail first-line treatment or are unwilling to receive first-line treatment;
- Disease progression occurred within 14 days before inclusion (RECIST criteria must be used as a basis for assessment of disease progression). According to RECIST V1.1, patients have at least one measurable lesion. Target lesions located within the field of previous therapeutic irradiation or within the area of local treatment (interventional or ablative treatment) are considered measurable if progress is confirmed;
- The main organs function normally and meet the following requirements;
Key exclusion criteria (12 listed)
- Pregnant or lactating women, pregnancy test positive by blood or urine within 48 hours before immune cell transplantation;
- Patients who need to be treated with systemic steroid;
- Under following treatment conditions currently:
- Receive radiotherapy within 4 weeks before enrollment;
- Patients who received any other cell therapy before;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KD-025 CAR-T cellsAutologous genetically modified anti-NKG2DLs CAR transduced T cells | Drug | KD-025 CAR-T cells |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 90 days post infusion
Incidence of dose-limiting toxicities
The occurrence of AEs and SAEs during the study treatment
Time frame: 0 to 28 days post infusion
An adverse event is any undesirable experience associated with the use of a medical product in a patient
3 secondary outcomes
Objective remission rate(ORR)
Time frame: 1 year post infusion
Progression free survival(PFS)
Time frame: 2 year post infusion
Overall survival (OS)
Time frame: 2 years post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD-025 CAR-T cells in people with Solid Tumor and Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 21 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baorui Liu, M.D (+025-83106666 ext 61331 ext. 61331, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 90 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?
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 23 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.