CRCEarly Phase 1NCT05382377
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
A Early Phase 1 study testing KD-025 in people with CRC and Solid Tumor, run by jianming xu 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
- CRC, Solid Tumor
- What is being tested?
- KD-025
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2022to 17 May 2026
- Phase
- Early 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 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 by Immunohistochemistry. 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
Chinese PLA General Hospital
Beijing, Beijing Municipality
Jianming Xu, MD, 13910866712, jianmingxu2014@163.com
About this study
Official title: A Single-center, Open-label, 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 tumors.
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
- CRC, Solid Tumor
- Being tested
- KD-025
- Keywords
- NKG2D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD-025Biological
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
| Study group | Role | What they receive |
|---|---|---|
| KD-025 cell infusion | Experimental | Each subject will receive KD-025 cell infusion Receives: Biological: KD-025 |
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 (3)
Objective response rate(ORR)
objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Measured: 1 month, 2 month, 3 month, 6 month, 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: 1 month, 2 month, 3 month, 6 month, 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: 1 month, 2 month, 3 month, 6 month, 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 May 2022
- Study start17 May 2022 (estimated)
- Primary completion17 May 2024 (estimated)
- Study completion17 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- jianming xu
- Sponsor type
- University, hospital or other
- Collaborators
- KAEDI
- Responsible party
- Sponsor-investigator, jianming xu, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382377
- Sponsor's protocol ID
- KD-025-XJM
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 19 May 2022
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-025 CAR-T Therapy in Advanced NKG2DL+ Solid Tumors
- ClinicalTrials.gov ID
- NCT05382377
- Acronym / sponsor ID
- KD-025-XJM
- Conditions
- CRC, Solid Tumor
- Keywords
- NKG2D
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- jianming xuUniversity, hospital or other
- Collaborators
- KAEDI
- Study start
- 17 May 2022 (estimated)
- Primary completion
- 17 May 2024 (estimated)
- Study completion
- 17 May 2026 (estimated)
- First posted
- 19 May 2022 (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 tumors.
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 |
|---|---|---|
| KD-025 cell infusion | Experimental | Biological: KD-025Each subject will receive KD-025 cell infusion |
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-025Autologous genetically modified anti-NKG2DLs CAR transduced T cells | Biological | KD-025 cell infusion |
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
3 secondary outcomes
Objective response rate(ORR)
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year after cell infusion
Progression free survival(PFS)
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year after cell infusion
Complete remission (CR)
Time frame: 1 month, 2 month, 3 month, 6 month, 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 May 2022.
- 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 Early Phase 1 study testing KD-025 in people with CRC and Solid Tumor, run by jianming xu 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 May 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jianming Xu, M.D (13910866712, jianmingxu2014@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 May 2022.