Solid TumorNCT06245018
A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor
A study testing iNK Injection in people with Solid Tumor, run by Nuwacell Biotechnologies Co., Ltd..
Trial summary
This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- iNK Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old.
- Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
- Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
- Have 1 or more focus can be accessed according to RECIST 1.1
- Eastern Cooperative Oncology Group(ECOG):0-1
- Expected survival period over 3 months
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- Have acceptable organ function and the results of laboratory examination meet the request below:
- Hepatic Insufficiency (ALT) and Aspartate aminotransferase（AST）≤3xULN(upper limit of normal);Total Bilirubin≤3xULN；Creatinine≤3xULN；White blood cell count ≥3.0x10^9/L; Absolute Neutrophil Count≥1.0x10^9/L
- Agree to contraception
- Subjects who understand and voluntarily sign the Informed Consent Form（ICF)
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms；
- With active infection during screening
- Have serious or uncontrolled basic diseases;
- Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety；
- Accept anti-tumor therapy within 28 days before first injection;
- Accept general anesthesia surgery or radiation therapy within 28 days before first injection;
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- Accept live vaccine or attenuated live vaccine within 28 days before first injection;
- Allergy to known drug components;
- Serous cavity effusion requiring clinical intervention；
- Pregnancy or prepare to pregnant during the treatment;
- Other situations that not suitable to participate into this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open, Dose Escalation and Extension Platform Trial to Evaluate the Safety, Pharmacological and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Natural Killer Cells (iNK) in Chinese Subjects With Solid Tumor
This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Read the detailed description
Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
- Conditions
- Solid Tumor
- Being tested
- iNK Injection
- Keywords
- iNK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNK InjectionBiological
Subjects will receive about 4 cycles of iNK
| Study group | Role | What they receive |
|---|---|---|
| iNK Injection | Experimental | Cohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection; Receives: Biological: iNK Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Measured: From the date of initial infusion to a year after initial infusion
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days after injection
Measured: 4 weeks after initial infusion
Secondary outcomes (3)
Objective Response Rate（ORR）
Percentage of participants achieved Complete Response(CR) or Partial Response(PR)
Measured: During the whole study
Disease Control Rate（DCR）
Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD)
Measured: From the date of initial infusion to a year after initial infusion
Duration Of Response（DOR）
Duration for the first PR to the first Progressive Disease(PD)
Measured: First Injection to a year after Last Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2030 (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.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245018
- Sponsor's protocol ID
- iNK-1002
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 7 Feb 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose Escalation and Extension Platform Trial to Evaluate the Safety, Pharmacological and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Natural Killer Cells (iNK) in Chinese Subjects With Solid Tumor
- ClinicalTrials.gov ID
- NCT06245018
- Acronym / sponsor ID
- iNK-1002
- Conditions
- Solid Tumor
- Keywords
- iNK
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 7 Feb 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 trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Detailed description
Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNK Injection | Experimental | Biological: iNK InjectionCohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years old.
- Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
- Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
- Have 1 or more focus can be accessed according to RECIST 1.1
- Eastern Cooperative Oncology Group(ECOG):0-1
Key exclusion criteria (11 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms；
- With active infection during screening
- Have serious or uncontrolled basic diseases;
- Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety；
- Accept anti-tumor therapy within 28 days before first injection;
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 |
|---|---|---|
| iNK InjectionSubjects will receive about 4 cycles of iNK | Biological | iNK Injection |
Primary outcome
Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE)
Time frame: From the date of initial infusion to a year after initial infusion
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)
Time frame: 4 weeks after initial infusion
Number of participants with Dose-limiting toxicity in 28 days after injection
3 secondary outcomes
Objective Response Rate（ORR）
Time frame: During the whole study
Disease Control Rate（DCR）
Time frame: From the date of initial infusion to a year after initial infusion
Duration Of Response（DOR）
Time frame: First Injection to a year after Last Injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A study testing iNK Injection in people with Solid Tumor, run by Nuwacell Biotechnologies Co., Ltd..
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 10 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: opening soon, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Gong (+8615221195602, xwgong@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE) (time frame: From the date of initial infusion to a year after initial 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 7 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.