Malignant TumorPhase 1/2NCT03931720
Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor
A Phase 1/2 study testing BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) in people with Malignant Tumor, run by Asclepius Technology Company Group (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2019to May 2022
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~75 years old, male or female
- Life expectancy ≥ 6 months
- ECOG score: 0-3
- ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
- Advanced solid tumor was diagnosed by pathological or clinical physicians
- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥70 x 10*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level
- Signed informed consent
- Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion
Who cannot join
- Expected overall survival < 6 months
- Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months
- Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine
Suzhou, Jiangsu, 215021
Fengchun Zhang, PhD, fczhang2004@163.com
About this study
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.
- Conditions
- Malignant Tumor
- Being tested
- BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)Biological
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) | Experimental | Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells). Receives: Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asclepius Technology Company Group (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931720
- Sponsor's protocol ID
- AsclepiusTCG
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 30 Apr 2019
- 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor
- ClinicalTrials.gov ID
- NCT03931720
- Acronym / sponsor ID
- AsclepiusTCG
- Conditions
- Malignant Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asclepius Technology Company Group (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 30 Apr 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.
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) | Experimental | Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18~75 years old, male or female
- Life expectancy ≥ 6 months
- ECOG score: 0-3
- ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
- Advanced solid tumor was diagnosed by pathological or clinical physicians
Key exclusion criteria (5 listed)
- Expected overall survival < 6 months
- Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months
- Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements
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 |
|---|---|---|
| BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)The subject will be observed for any side effects during this time and all the adverse events will be recorded. | Biological | anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) |
Primary outcome
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Time frame: 1 year
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- 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 1/2 study testing BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) in people with Malignant Tumor, run by Asclepius Technology Company Group (Suzhou) Co., Ltd. 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 8 inclusion and 5 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 30 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangfu Li (+86 13615181959, lgf@atcgcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related adverse events as assessed by CTCAE v4.03 (time frame: 1 year). 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 30 Apr 2019.