Malignant Solid TumorEarly Phase 1NCT04076137
Targeted T-cell Therapy in Solid Tumors
A Early Phase 1 study testing Targeted T-cell armed with bispecific antibody (Decitabine) in people with Malignant Solid Tumor, run by Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- Targeted T-cell armed with bispecific antibody (Decitabine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 May 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:1. Age: 18~75 years old; 2. Patients with solid tumors still show progress after radiotherapy, chemotherapy and targeted therapy, with at least one measurable lesion; 3. No congenital autoimmune diseases or immunodeficiency diseases;' 4. At least one or more solid tumor targets of HER2, MUC1, CEA, EGFR and GPC3 were positive by immunohistochemical examination of tumor tissues; 5. No serious infectious diseases (hepatitis b, c, syphilis, AIDS); 6. Sign informed consent voluntarily. -
Exclusion Criteria:1. The researchers determined that the patient could not complete 6 courses of treatment.
- Patients with t-cell lymphoma. 3. Pregnant or lactating female patients, or those who do not want to use contraception during the trial.
- Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.
- Other patients in the treated group who were considered as unfit for cell therapy.
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of oncology, the second people's hospital of shenzhen
Shenzhen, Guangdong, 518055
Zhengcheng Li, Doctor, +86-0755-26912981 ext. 6037, lizhengcheng07@163.com
About this study
Official title: Clinical Study of Targeted T-cell Therapy in Solid Tumors
This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.
Read the detailed description
In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.
- Conditions
- Malignant Solid Tumor
- Being tested
- Targeted T-cell armed with bispecific antibody (Decitabine)
- Keywords
- Targeted T-cell, HER2, MUC1, CEA, EGFR, GPC3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted T-cell armed with bispecific antibody (Decitabine)Other
Also called decitabine
In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.
| Study group | Role | What they receive |
|---|---|---|
| Targeted T-cell | Experimental | This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses. Receives: Other: Targeted T-cell armed with bispecific antibody (Decitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overrall survival.The time of patient from randomization to death caused by any cause.
Measured: 1 year .
Secondary outcomes (1)
PFS
Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.
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 posted3 Sep 2019
- Study start1 May 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, open, single-arm controlled prospective clinical study to investigate the efficacy and safety of targeted T-cell therapy in solid tumors.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- Zeqiang Zhou, Doctor, Study chair, Department of oncology, the second people's hospital of shenzhenWenli Liang, Doctor, Study director, Department of oncology, the second people's hospital of shenzhenLiang Xiao, Doctor, Principal investigator, Department of oncology, the second people's hospital of shenzhenLin Lin, Doctor, Principal investigator, Department of oncology, the second people's hospital of shenzhenMeixiang Li, Doctor, Principal investigator, Department of oncology, the second people's hospital of shenzhen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076137
- Sponsor's protocol ID
- BK2019.01
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Targeted T-cell Therapy in Solid Tumors
- ClinicalTrials.gov ID
- NCT04076137
- Acronym / sponsor ID
- BK2019.01
- Conditions
- Malignant Solid Tumor
- Keywords
- Targeted T-cell, HER2, MUC1, CEA, EGFR, GPC3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Second People's Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 3 Sep 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.
This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.
Detailed description
In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, open, single-arm controlled prospective clinical study to investigate the efficacy and safety of targeted T-cell therapy in solid tumors.
| Arm | Type | Receives |
|---|---|---|
| Targeted T-cell | Experimental | Other: Targeted T-cell armed with bispecific antibody (Decitabine)This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Targeted T-cell armed with bispecific antibody (Decitabine)Also: decitabineIn this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group. | Other | Targeted T-cell |
Primary outcome
OS
Time frame: 1 year .
Overrall survival.The time of patient from randomization to death caused by any cause.
1 secondary outcome
PFS
Time frame: 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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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.
Zeqiang Zhou, Doctor study chair
Department of oncology, the second people's hospital of shenzhen
Wenli Liang, Doctor study director
Department of oncology, the second people's hospital of shenzhen
Liang Xiao, Doctor principal investigator
Department of oncology, the second people's hospital of shenzhen
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 Targeted T-cell armed with bispecific antibody (Decitabine) in people with Malignant Solid Tumor, run by Benhealth Biopharmaceutical (Shenzhen) 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?
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 3 Sep 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 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 Zhengzheng Li, Doctor (0755-26912981 ext. 6037, lizhengcheng07@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (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 3 Sep 2019.