Anti-cancer Cell ImmunotherapyPhase 1/2NCT03882840
Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I
A Phase 1/2 study testing ITNK cell therapy in people with Anti-cancer Cell Immunotherapy and T Cell and NK Cell, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-cancer Cell Immunotherapy, T Cell and NK Cell
- What is being tested?
- ITNK cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2035
- Phase
- Phase 1/2
- 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
- Patients with advanced cancer, which express low or no MHC-I.
- Life expectancy >12 weeks
- Adequate heart,lung,liver,kidney function
- Available autologous T cells
- Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.
Who cannot join
- Had accepted gene therapy before;
- Severe virus infection such as HBV,HCV,HIV,et al
- Known HIV positivity
- History of liver or other organ transplantation
- Active infectious disease related to bacteria, virus,fungi,et al
- Other severe diseases that the investigators consider not appropriate;
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- Pregnant or lactating women
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
- Other conditions that the investigators consider not appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peng Li, PhD contact
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Zhenfeng Zhang, MD,PhD, +86-020-34153532, zhangzhf@gzhmu.edu.cn
Peng Li, PhD
About this study
Official title: Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression
T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.
Read the detailed description
One gene can be knockout of the T cells to produce a T-like NK cells which obtain killing function of both T effector cells and NK cells. We will collect appropriate patient's T cells, produce T-like NK cells (ITNK), and infuse the ITNK/CAR-ITNK cells back to the patients to treat various of cancers.
- Conditions
- Anti-cancer Cell Immunotherapy, T Cell and NK Cell
- Being tested
- ITNK cell therapy
- Keywords
- Solid Tumor, ITNK, CAR-ITNK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITNK cell therapyBiological
Infusion of ITNK/CAR-ITNK cells
| Study group | Role | What they receive |
|---|---|---|
| ITNK cell therapy group | Experimental | Patient-originated and induced T-to-natural killer (ITNK) cells, will be administrated to kill tumor cells. Receives: Biological: ITNK cell therapy |
| CAR-ITNK cell therapy group | Experimental | Patient-originated and induced T-to-natural killer (ITNK) cells with CAR-engineered, will be administrated to kill tumor cells. Receives: Biological: ITNK cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerance of the ITNK cell immunotherapy
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ITNK cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. Incidence of treatment-emergent adverse events will be calculated as standard methods.
Measured: 2 years
Secondary outcomes (1)
Percent of Patients with best response as either complete remission or partial remission.
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anti-cancer Cell ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882840
- Sponsor's protocol ID
- ZZITNK-007
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2019
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li P, Burke S, Wang J, Chen X, Ortiz M, Lee SC, Lu D, Campos L, Goulding D, Ng BL, Dougan G, Huntly B, Gottgens B, Jenkins NA, Copeland NG, Colucci F, Liu P. Reprogramming of T cells to natural killer-like cells upon Bcl11b deletion. Science. 2010 Jul 2;329(5987):85-9. doi: 10.1126/science.1188063. Epub 2010 Jun 10.
PubMed 20538915Jiang Z, Qin L, Tang Y, Liao R, Shi J, He B, Li S, Zheng D, Cui Y, Wu Q, Long Y, Yao Y, Wei Z, Hong Q, Wu Y, Mai Y, Gou S, Li X, Weinkove R, Norton S, Luo W, Feng W, Zhou H, Liu Q, Chen J, Lai L, Chen X, Pei D, Graf T, Liu X, Li Y, Liu P, Zhang Z, Li P. Human induced-T-to-natural killer cells have potent anti-tumour activities. Biomark Res. 2022 Mar 24;10(1):13. doi: 10.1186/s40364-022-00358-4.
PubMed 35331335
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression
- ClinicalTrials.gov ID
- NCT03882840
- Acronym / sponsor ID
- ZZITNK-007
- Conditions
- Anti-cancer Cell Immunotherapy, T Cell and NK Cell
- Keywords
- Solid Tumor, ITNK, CAR-ITNK
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 20 Mar 2019 (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.
T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.
Detailed description
One gene can be knockout of the T cells to produce a T-like NK cells which obtain killing function of both T effector cells and NK cells. We will collect appropriate patient's T cells, produce T-like NK cells (ITNK), and infuse the ITNK/CAR-ITNK cells back to the patients to treat various of cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITNK cell therapy group | Experimental | Biological: ITNK cell therapyPatient-originated and induced T-to-natural killer (ITNK) cells, will be administrated to kill tumor cells. |
| CAR-ITNK cell therapy group | Experimental | Biological: ITNK cell therapyPatient-originated and induced T-to-natural killer (ITNK) cells with CAR-engineered, will be administrated to kill tumor cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced cancer, which express low or no MHC-I.
- Life expectancy >12 weeks
- Adequate heart,lung,liver,kidney function
- Available autologous T cells
- Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.
Key exclusion criteria (9 listed)
- Had accepted gene therapy before;
- Severe virus infection such as HBV,HCV,HIV,et al
- Known HIV positivity
- History of liver or other organ transplantation
- Active infectious disease related to bacteria, virus,fungi,et al
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 |
|---|---|---|
| ITNK cell therapyInfusion of ITNK/CAR-ITNK cells | Biological | CAR-ITNK cell therapy group, ITNK cell therapy group |
Primary outcome
The safety and tolerance of the ITNK cell immunotherapy
Time frame: 2 years
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ITNK cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. Incidence of treatment-emergent adverse events will be calculated as standard methods.
1 secondary outcome
Percent of Patients with best response as either complete remission or partial remission.
Time frame: 2 years
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 26 Jun 2024.
- Background: PubMed 20538915Li P, Burke S, Wang J, Chen X, Ortiz M, Lee SC, Lu D, Campos L, Goulding D, Ng BL, Dougan G, Huntly B, Gottgens B, Jenkins NA, Copeland NG, Colucci F, Liu P. Reprogramming of T cells to natural killer-like cells upon Bcl11b deletion. Science. 2010 Jul 2;329(5987):85-9. doi: 10.1126/science.1188063. Epub 2010 Jun 10.
- Derived from this study: PubMed 35331335Jiang Z, Qin L, Tang Y, Liao R, Shi J, He B, Li S, Zheng D, Cui Y, Wu Q, Long Y, Yao Y, Wei Z, Hong Q, Wu Y, Mai Y, Gou S, Li X, Weinkove R, Norton S, Luo W, Feng W, Zhou H, Liu Q, Chen J, Lai L, Chen X, Pei D, Graf T, Liu X, Li Y, Liu P, Zhang Z, Li P. Human induced-T-to-natural killer cells have potent anti-tumour activities. Biomark Res. 2022 Mar 24;10(1):13. doi: 10.1186/s40364-022-00358-4.
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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.
Peng Li, PhD contact
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ITNK cell therapy in people with Anti-cancer Cell Immunotherapy and T Cell and NK Cell, run by Second Affiliated Hospital of Guangzhou Medical University 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 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhenfeng Zhang, MD,PhD (+862034153532, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerance of the ITNK cell immunotherapy (time frame: 2 years). 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 NCT03882840, which also lists 2 linked publications.
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 26 Jun 2024.