Safety IssuesNCT06509490
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
A study testing KD-025 cell injection in people with Safety Issues, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 advanced NKG2DL+ solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- KD-025 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2024to 26 Mar 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as ovarian, cholangiocarcinoma, and colorectal cancer.
- Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations refer to the latest version of the guidelines of the national comprehensive cancer network (NCCN) or the guidelines of the Chinese society of Clinical Oncology (CSCO);
- Age 18-70 years;
- ECOG score 0-1;
- Expected survival ≥ 3 months;
- Patients must meet coagulation parameters and have adequate peripheral venous access for apheresis, and must also have enough PBMC to manufacture CAR T cells;
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- NKG2DL (according to the positive comprehensive score of 0-12 points, positive SCORE of NKG2DL ≥2) positive confirmed byImmunohistochemistry. Biopsy tissue must be no more than 1 year, if not, must obtain new tissue material from a recent surgical or diagnostic biopsy;
- Eligible organ and bone marrow functions defined as follows:1) Absolute neutrophil count ≥1.5×10^9/L, lymphocyte count ≥0.5×10^9/ L, platelet count ≥90×10^9/L, hemoglobin ≥90g/L (no blood transfusion or Erythropoietin within 7 days); 2) Total bilirubin ≤2ULN; Serum alanine amino transferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN (≤2.5 times with liver metastasis); 3) Creatinine ≤1.5ULN or eGFR≥ 60mL /min/1.73m^2 [eGFR=186×(age)-0.203×SCr-1.154(mg/dl), eGFR timing in women was 0.742]; 4) International normalized ratio (INR) or prothrombin time (PT) ≤1.5ULN; 5) Lung function: ≤ grade 1 dyspnea (according to NCI-CTCAE V5.0), SaO2≥91%; 6) Cardiac function: Cardiac ejection fraction (LVEF) detected by echocardiography or MUGA ≥50% 1 month before enrollment.
- Patients must have measurable lesions as defined by RECIST 1.1;
- Patients fully understand the test and voluntarily sign the informed consent;
- Patient agree to use approved contraceptive methods (e.g., birth control pills, barrier devices, iuds, contraindicated drugs) during the study and for at least 12 months after last cell infusion, until no CAR-T cells were detected by two consecutive PCR tests.
Who cannot join
- Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy, Active bacteria or viral or fungal infection and not controlled after anti-infective treatment (positive blood test 72 hours before infusion), Syphilis, Human immunodeficiency virus (HIV), Active hepatitis B (HBV DNA≥500IU/ml) or hepatitis c (anti-HCV positive and HCV RNA higher than the detection limit of analysis method);
- Patients have an autoimmune disease or organ transplant, require chronic systemic steroid therapy or any other form of immunosuppressive drugs;
- A history of serious heart or lung disease, including uncontrolled hypertension medication, and any condition that occurred within the past 6 months: congestive heart failure (New York Heart Association functional classification ≥3), cardiac angioplasty and stents, myocardial infarction, unstable angina, or other clinically severe heart disease;
- Detected clinically relevant central nervous system (CNS) metastases and/or pathologies, such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases or autoimmune diseases affecting the CNS;
- The Patients' history or existing evidence of any condition such as neuroticism, psychosis, immunology, metabolism, and infectious disease, in any treatment, or laboratory abnormalities may confuse the outcome of the study, interfere with the Patients' participation during the study, or not participate in the Patients' best interests with investigator treatment;
- The Patients have a history of hematologic malignancy or concurrent history of other malignant primary solid tumors, except for: 1) Patients with cervical or breast cancer in situ who have no evidence of disease for more than 3 years after radical treatment; 2) Patients who have successfully received definite resection of tumor in situ and have no evidence of disease for ≥5 years;
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- Received chemotherapy, radiation, small molecule, biologic cancer therapy, immunotherapy, or other experimental drugs within 4 weeks prior to study initiation,
- Pregnant or lactating women;
- The investigator considers the Patients have or with current historical evidence of any condition, therapy, or laboratory anomaly that may confound the results of the study, interfere with the Patients' participation in the fulltime study and the requirements of the cooperative trial, not controlled medical, psychological, family, social, or geographic conditions, or not participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuan Fang, MD, 010-87788165
About this study
Official title: A Single-center, Open, Single-arm Clinical Study of the Safety and Efficacy of KD-025 CAR-T Therapy in Advanced NKG2DL+ Solid 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 advanced NKG2DL+ solid tumors.
Read the detailed description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of KD-025 cell infusion in patients with advanced NKG2DL+ solid tumor. In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be undergo screening, pre-treatment (cell product preparation;lymphodepleting chemotherapy), treatment and follow up
- Conditions
- Safety Issues
- Being tested
- KD-025 cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD-025 cell injectionDrug
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of KD-025 cell infusion in patients with advanced NKG2DL+ solid tumor. In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be undergo screening, pre-treatment (cell product preparation;lymphodepleting chemotherapy), treatment and follow up
| Study group | Role | What they receive |
|---|---|---|
| KD025 | Experimental | This group of patients received KD025 cell injection. Receives: Drug: KD-025 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-emergent adverse events(TEAEs)
An adverse event is any undesirable experience associated with the use of a medical product in a patient
Measured: 3 months after single infusion
Dose-limiting toxicity (DLT) rate
A drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Measured: 3 months after single infusion
CAR positive T cells in patients
The time of CAR-T cell reach the peak and turn back to baseline
Measured: 6 months after single infusion
Secondary outcomes (4)
Objective response rate(ORR)
objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Measured: 1month,2month,3month,6month,1 year after cell infusion]
Progression free survival(PFS)
the time from the date of first infusion of the KD-025 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
Measured: 1month,2month,3month,6month,1 year after cell infusion]
Overall survival #OS#
the time from the date of first infusion of KD-025 to death of the subject
Measured: 1month,2month,3month,6month,1 year after cell infusion
Complete remission (CR)
the time from the date of first infusion of KD-025 to death of the subject
Measured: 1month,2month,3month,6month,1 year after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start17 Jul 2024 (estimated)
- Primary completion26 Jul 2024 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NING_LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning Li, MD, Principal investigator, NCCICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509490
- Sponsor's protocol ID
- KD-025-XJM
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Single-arm Clinical Study of the Safety and Efficacy of KD-025 CAR-T Therapy in Advanced NKG2DL+ Solid Tumors
- ClinicalTrials.gov ID
- NCT06509490
- Acronym / sponsor ID
- KD-025-XJM
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 17 Jul 2024 (estimated)
- Primary completion
- 26 Jul 2024 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 19 Jul 2024 (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 advanced NKG2DL+ solid tumors.
Detailed description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of KD-025 cell infusion in patients with advanced NKG2DL+ solid tumor. In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be undergo screening, pre-treatment (cell product preparation;lymphodepleting chemotherapy), treatment and 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 |
|---|---|---|
| KD025 | Experimental | Drug: KD-025 cell injectionThis group of patients received KD025 cell injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as ovarian, cholangiocarcinoma, and colorectal cancer.
- Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations refer to the latest version of the guidelines of the national comprehensive cancer network (NCCN) or the guidelines of the Chinese society of Clinical Oncology (CSCO);
- Age 18-70 years;
- ECOG score 0-1;
- Expected survival ≥ 3 months;
Key exclusion criteria (9 listed)
- Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy, Active bacteria or viral or fungal infection and not controlled after anti-infective treatment (positive blood test 72 hours before infusion), Syphilis, Human immunodeficiency virus (HIV), Active hepatitis B (HBV DNA≥500IU/ml) or hepatitis c (anti-HCV positive and HCV RNA higher than the detection limit of analysis method);
- Patients have an autoimmune disease or organ transplant, require chronic systemic steroid therapy or any other form of immunosuppressive drugs;
- A history of serious heart or lung disease, including uncontrolled hypertension medication, and any condition that occurred within the past 6 months: congestive heart failure (New York Heart Association functional classification ≥3), cardiac angioplasty and stents, myocardial infarction, unstable angina, or other clinically severe heart disease;
- Detected clinically relevant central nervous system (CNS) metastases and/or pathologies, such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases or autoimmune diseases affecting the CNS;
- The Patients' history or existing evidence of any condition such as neuroticism, psychosis, immunology, metabolism, and infectious disease, in any treatment, or laboratory abnormalities may confuse the outcome of the study, interfere with the Patients' participation during the study, or not participate in the Patients' best interests with investigator treatment;
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 cell injectionThis is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of KD-025 cell infusion in patients with advanced NKG2DL+ solid tumor. In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be undergo screening, pre-treatment (cell product preparation;lymphodepleting chemotherapy), treatment and follow up | Drug | KD025 |
Primary outcome
treatment-emergent adverse events(TEAEs)
Time frame: 3 months after single infusion
An adverse event is any undesirable experience associated with the use of a medical product in a patient
Dose-limiting toxicity (DLT) rate
Time frame: 3 months after single infusion
A drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
CAR positive T cells in patients
Time frame: 6 months after single infusion
The time of CAR-T cell reach the peak and turn back to baseline
4 secondary outcomes
Objective response rate(ORR)
Time frame: 1month,2month,3month,6month,1 year after cell infusion]
Progression free survival(PFS)
Time frame: 1month,2month,3month,6month,1 year after cell infusion]
Overall survival #OS#
Time frame: 1month,2month,3month,6month,1 year after cell infusion
Complete remission (CR)
Time frame: 1month,2month,3month,6month,1 year after cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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.
Ning Li, MD principal investigator
NCCICAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KD-025 cell injection in people with Safety Issues, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 inclusion and 9 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 19 Jul 2024. 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.
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 Ning Li, MD (010-87788165, cancergcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-emergent adverse events(TEAEs) (time frame: 3 months after single infusion). The study lists 3 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 19 Jul 2024.