Liver Cancer Stage IVPhase 1NCT03159585
To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors
A Phase 1 study testing TAEST16001 in people with Liver Cancer Stage IV and Gastric Cancer Stage IV, run by Zhujiang Hospital at 1 site in China.
Trial summary
The main purpose of this trial is to investigate the safety and tolerability of TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer Stage IV, Gastric Cancer Stage IV, Esophageal Cancer, Stage IV
- What is being tested?
- TAEST16001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2017to 4 Jun 2019
- Phase
- 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
Who may be able to join
- sign an informed consent before undertaking any trial-related activities;
- ≥18 and ≤75 years old;
- Multi-line treatment failed Solid Tumors except non small cell lung cancer,including Liver Cancer,Gastric Cancer,Esophageal Cancer,Bone and Soft Tissue Tumors,Breast Cancer, Bladder Carcinoma,Prostate Carcinoma,Thyroid Cancer, Ovarian Cancer and so on diagnosed by licensed pathologist;
- multi-line treatment failed patients;
- with measurable lesions according to Response Evaluation Criteria In Solid Tumors1.1 or immune related response criteria standard;
- meet the two screening indicators: HLA-A*0201+, NYESO-1+(≥25% by immunohistochemistry);
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- Eastern Cooperative Oncology Group score 0-1;life expectancy is longer than 3 months;
- The patient did not receive anti-tumor therapy within 4 weeks before enrollment;
- A brain metastasis patient in a stable condition for one month after anti-tumor therapy can be included;
- left ventricular ejection fraction≥50%
- Lab test results meet the following requirements:
- white blood cell count≥3.0×10^9/L; absolute neutrophil count≥1.5 ×10^9/L (No human granulocyte colony stimulating factor support); blood platelet≥75 ×10^9/L; Hemoglobin≥10g/dL (No transfusion in the last 7 days); Prothrombin time or International normalized rate ≤1.5×normal upper limit, except taking anticoagulant therapy; thrombin time≤1.5×normal upper limit, except taking anticoagulant therapy; a 24-hour creatinine clearance rate≥60mL/ min; Aspartate transaminase / serum glutamic oxaloacetic transaminase≤2.5 ×upper limit of normal; Alanine aminotransferase/ serum glutamate pyruvate transaminase≤2.5 ×upper limit of normal; total bilirubin≤1.5×upper limit of normal (expect that the subject has Gilbert's syndrome).
- no pregnant women；female patients must use contraceptive measures during the study and prohibit any homosexual or heterosexual;
- The patients can regularly visit the research institutions for related tests, evaluations, and management during the study period.
Who cannot join
- lung cancer ;
- received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy 4 weeks before enrollment;
- allergic to ingredients in this trial;
- common terminology criteria for adverse events ≥2 because of the previous surgery or treatment-related adverse reactions;
- with two types of primary solid tumors;
- poorly managed hypertension (systolic blood pressure >160 mmHg and / or diastolic blood pressure > 90 mmHg) or clinically serious (for example, active) cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; with consecutive three times of obvious abnormality on electrocardiogram or average QT corrected interval ≥450 millisecond;
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- combined with other serious organic and mental disorders;
- serious or active bacteria, viral or fungal infections that require systemic treatment;
- with autoimmune diseases: such as a history of inflammatory bowel disease or other autoimmune diseases determined by the investigator as unsuitable for the study (e.g. systemic lupus erythematosus,vasculitis, invasive pulmonary disease);
- within 4 weeks prior the infusion, received chronic systemic steroid cortisone, hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gamma interferon, granulocyte colony stimulating factor, mammalian target of rapamycin inhibitors, cyclosporine, Thymosin etc);
- with organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy;
- with central nervous system metastasis but not receive treatment;
- with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure;
- alcohol and / or drug abuse;
- pregnant or lactating women;
- received concomitant medication prohibited by this trial;
- with any medical condition or disease determined by the investigators that may be detrimental to this trial;
- without legal capacity / limited behavior.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital of Southern Mediacl University
Guangzhou, Guangdong, 510282
About this study
Official title: Application of NY-ESO-1-specific TCR Affinity Enhancing Specific T Cell Therapy (TAEST16001) in Solid Tumors Except Non Small Cell Lung Cancer,Including Liver Cancer,Gastric Cancer,Esophageal Cancer and so on.
The main purpose of this trial is to investigate the safety and tolerability of TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.
Read the detailed description
TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma and 55% melanoma had benefits, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy. The US FDA has granted breakthrough TCR-T cell therapy for patients with inoperable or metastatic synovial sarcoma. The European Medicines Agency has also approved the same therapy to Priority Medicines(PRIME).
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on other solid tumors is still unknown. So we plan to explore its efficacy in many types of solid tumors.
The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.
- Conditions
- Liver Cancer Stage IV, Gastric Cancer Stage IV, Esophageal Cancer, Stage IV, Bone and Soft Tissue Tumors, Breast Cancer Stage IV, Bladder Carcinoma Stage IV
- Being tested
- TAEST16001
- Keywords
- TAEST16001
- Medical subject headings
- Liver Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Soft Tissue Neoplasms, Breast Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAEST16001Drug
After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001
| Study group | Role | What they receive |
|---|---|---|
| TAEST16001 | Experimental | Patients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide. Receives: Drug: TAEST16001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-related adverse events as assessed by CTCAE v4.03
The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03
Measured: 28 Days
Secondary outcomes (6)
assess overall response rate
The overall response rate is evaluated according to Response Evaluation Criteria In Solid Tumors or Immune Related Response Criteria
Measured: 270 Days
assess duration of response
The efficacy of TAEST16001 will be assessed by duration of response(DOR).The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
Measured: 270 Days
assess time to progress
The efficacy of TAEST16001 will be assessed by time to progress (TTP).The TTP refers to the time from treatment to disease progression
Measured: 270 Days
assess progression free survival
The efficacy of TAEST16001 will be assessed by progression free survival (PFS).The PFS refers to the time from treatment to progressive disease or death for any reason
Measured: 270 Days
assess overall survival
The efficacy of TAEST16001 will be assessed by overall survival (OS).The OS refers to the time from treatment to death
Measured: 270 Days
assess the expression of tumor markers
The efficacy of TAEST16001 will be assessed by tumor markers including carcinoembryonic antigen,carbohydrate antigen199,carbohydrate antigen125,prostate specific antigen,alpha fetoprotein,carbohydrate antigen724.
Measured: 270 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start14 Apr 2017
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single-center, open, single (or fractional) dose of safety and tolerability
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangxue Life Science Research Center, Guangdong Xiangxue Precision Medical Technology Co., Ltd., Xiangxue Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159585
- Sponsor's protocol ID
- 2017-ZLZX-001
- Status last verified
- Jan 2020
- First submitted
- 15 May 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rapoport AP, Stadtmauer EA, Binder-Scholl GK, Goloubeva O, Vogl DT, Lacey SF, Badros AZ, Garfall A, Weiss B, Finklestein J, Kulikovskaya I, Sinha SK, Kronsberg S, Gupta M, Bond S, Melchiori L, Brewer JE, Bennett AD, Gerry AB, Pumphrey NJ, Williams D, Tayton-Martin HK, Ribeiro L, Holdich T, Yanovich S, Hardy N, Yared J, Kerr N, Philip S, Westphal S, Siegel DL, Levine BL, Jakobsen BK, Kalos M, June CH. NY-ESO-1-specific TCR-engineered T cells mediate sustained antigen-specific antitumor effects in myeloma. Nat Med. 2015 Aug;21(8):914-921. doi: 10.1038/nm.3910. Epub 2015 Jul 20.
PubMed 26193344Li Y, Moysey R, Molloy PE, Vuidepot AL, Mahon T, Baston E, Dunn S, Liddy N, Jacob J, Jakobsen BK, Boulter JM. Directed evolution of human T-cell receptors with picomolar affinities by phage display. Nat Biotechnol. 2005 Mar;23(3):349-54. doi: 10.1038/nbt1070. Epub 2005 Feb 20.
PubMed 15723046Robbins PF, Kassim SH, Tran TL, Crystal JS, Morgan RA, Feldman SA, Yang JC, Dudley ME, Wunderlich JR, Sherry RM, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Li YF, El-Gamil M, Rosenberg SA. A pilot trial using lymphocytes genetically engineered with an NY-ESO-1-reactive T-cell receptor: long-term follow-up and correlates with response. Clin Cancer Res. 2015 Mar 1;21(5):1019-27. doi: 10.1158/1078-0432.CCR-14-2708. Epub 2014 Dec 23.
PubMed 25538264Robbins PF, Morgan RA, Feldman SA, Yang JC, Sherry RM, Dudley ME, Wunderlich JR, Nahvi AV, Helman LJ, Mackall CL, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Levy CL, Li YF, El-Gamil M, Schwarz SL, Laurencot C, Rosenberg SA. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011 Mar 1;29(7):917-24. doi: 10.1200/JCO.2010.32.2537. Epub 2011 Jan 31.
PubMed 21282551Johnson LA, Morgan RA, Dudley ME, Cassard L, Yang JC, Hughes MS, Kammula US, Royal RE, Sherry RM, Wunderlich JR, Lee CC, Restifo NP, Schwarz SL, Cogdill AP, Bishop RJ, Kim H, Brewer CC, Rudy SF, VanWaes C, Davis JL, Mathur A, Ripley RT, Nathan DA, Laurencot CM, Rosenberg SA. Gene therapy with human and mouse T-cell receptors mediates cancer regression and targets normal tissues expressing cognate antigen. Blood. 2009 Jul 16;114(3):535-46. doi: 10.1182/blood-2009-03-211714. Epub 2009 May 18.
PubMed 19451549Morgan RA, Dudley ME, Wunderlich JR, Hughes MS, Yang JC, Sherry RM, Royal RE, Topalian SL, Kammula US, Restifo NP, Zheng Z, Nahvi A, de Vries CR, Rogers-Freezer LJ, Mavroukakis SA, Rosenberg SA. Cancer regression in patients after transfer of genetically engineered lymphocytes. Science. 2006 Oct 6;314(5796):126-9. doi: 10.1126/science.1129003. Epub 2006 Aug 31.
PubMed 16946036
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of NY-ESO-1-specific TCR Affinity Enhancing Specific T Cell Therapy (TAEST16001) in Solid Tumors Except Non Small Cell Lung Cancer,Including Liver Cancer,Gastric Cancer,Esophageal Cancer and so on.
- ClinicalTrials.gov ID
- NCT03159585
- Acronym / sponsor ID
- 2017-ZLZX-001
- Conditions
- Liver Cancer Stage IV, Gastric Cancer Stage IV, Esophageal Cancer, Stage IV, Bone and Soft Tissue Tumors, Breast Cancer Stage IV, Bladder Carcinoma Stage IV
- Keywords
- TAEST16001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Xiangxue Life Science Research Center, Guangdong Xiangxue Precision Medical Technology Co., Ltd., Xiangxue Pharmaceutical
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 18 May 2017 (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.
The main purpose of this trial is to investigate the safety and tolerability of TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.
Detailed description
TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma and 55% melanoma had benefits, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy. The US FDA has granted breakthrough TCR-T cell therapy for patients with inoperable or metastatic synovial sarcoma. The European Medicines Agency has also approved the same therapy to Priority Medicines(PRIME).
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on other solid tumors is still unknown. So we plan to explore its efficacy in many types of solid tumors.
The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single-center, open, single (or fractional) dose of safety and tolerability
| Arm | Type | Receives |
|---|---|---|
| TAEST16001 | Experimental | Drug: TAEST16001Patients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- sign an informed consent before undertaking any trial-related activities;
- ≥18 and ≤75 years old;
- Multi-line treatment failed Solid Tumors except non small cell lung cancer,including Liver Cancer,Gastric Cancer,Esophageal Cancer,Bone and Soft Tissue Tumors,Breast Cancer, Bladder Carcinoma,Prostate Carcinoma,Thyroid Cancer, Ovarian Cancer and so on diagnosed by licensed pathologist;
- multi-line treatment failed patients;
- with measurable lesions according to Response Evaluation Criteria In Solid Tumors1.1 or immune related response criteria standard;
Key exclusion criteria (18 listed)
- lung cancer ;
- received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy 4 weeks before enrollment;
- allergic to ingredients in this trial;
- common terminology criteria for adverse events ≥2 because of the previous surgery or treatment-related adverse reactions;
- with two types of primary solid tumors;
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 |
|---|---|---|
| TAEST16001After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001 | Drug | TAEST16001 |
Primary outcome
treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 28 Days
The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03
6 secondary outcomes
assess overall response rate
Time frame: 270 Days
assess duration of response
Time frame: 270 Days
assess time to progress
Time frame: 270 Days
assess progression free survival
Time frame: 270 Days
assess overall survival
Time frame: 270 Days
assess the expression of tumor markers
Time frame: 270 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 26193344Rapoport AP, Stadtmauer EA, Binder-Scholl GK, Goloubeva O, Vogl DT, Lacey SF, Badros AZ, Garfall A, Weiss B, Finklestein J, Kulikovskaya I, Sinha SK, Kronsberg S, Gupta M, Bond S, Melchiori L, Brewer JE, Bennett AD, Gerry AB, Pumphrey NJ, Williams D, Tayton-Martin HK, Ribeiro L, Holdich T, Yanovich S, Hardy N, Yared J, Kerr N, Philip S, Westphal S, Siegel DL, Levine BL, Jakobsen BK, Kalos M, June CH. NY-ESO-1-specific TCR-engineered T cells mediate sustained antigen-specific antitumor effects in myeloma. Nat Med. 2015 Aug;21(8):914-921. doi: 10.1038/nm.3910. Epub 2015 Jul 20.
- Background: PubMed 15723046Li Y, Moysey R, Molloy PE, Vuidepot AL, Mahon T, Baston E, Dunn S, Liddy N, Jacob J, Jakobsen BK, Boulter JM. Directed evolution of human T-cell receptors with picomolar affinities by phage display. Nat Biotechnol. 2005 Mar;23(3):349-54. doi: 10.1038/nbt1070. Epub 2005 Feb 20.
- Background: PubMed 25538264Robbins PF, Kassim SH, Tran TL, Crystal JS, Morgan RA, Feldman SA, Yang JC, Dudley ME, Wunderlich JR, Sherry RM, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Li YF, El-Gamil M, Rosenberg SA. A pilot trial using lymphocytes genetically engineered with an NY-ESO-1-reactive T-cell receptor: long-term follow-up and correlates with response. Clin Cancer Res. 2015 Mar 1;21(5):1019-27. doi: 10.1158/1078-0432.CCR-14-2708. Epub 2014 Dec 23.
- Background: PubMed 21282551Robbins PF, Morgan RA, Feldman SA, Yang JC, Sherry RM, Dudley ME, Wunderlich JR, Nahvi AV, Helman LJ, Mackall CL, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Levy CL, Li YF, El-Gamil M, Schwarz SL, Laurencot C, Rosenberg SA. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011 Mar 1;29(7):917-24. doi: 10.1200/JCO.2010.32.2537. Epub 2011 Jan 31.
- Background: PubMed 19451549Johnson LA, Morgan RA, Dudley ME, Cassard L, Yang JC, Hughes MS, Kammula US, Royal RE, Sherry RM, Wunderlich JR, Lee CC, Restifo NP, Schwarz SL, Cogdill AP, Bishop RJ, Kim H, Brewer CC, Rudy SF, VanWaes C, Davis JL, Mathur A, Ripley RT, Nathan DA, Laurencot CM, Rosenberg SA. Gene therapy with human and mouse T-cell receptors mediates cancer regression and targets normal tissues expressing cognate antigen. Blood. 2009 Jul 16;114(3):535-46. doi: 10.1182/blood-2009-03-211714. Epub 2009 May 18.
- Background: PubMed 16946036Morgan RA, Dudley ME, Wunderlich JR, Hughes MS, Yang JC, Sherry RM, Royal RE, Topalian SL, Kammula US, Restifo NP, Zheng Z, Nahvi A, de Vries CR, Rogers-Freezer LJ, Mavroukakis SA, Rosenberg SA. Cancer regression in patients after transfer of genetically engineered lymphocytes. Science. 2006 Oct 6;314(5796):126-9. doi: 10.1126/science.1129003. Epub 2006 Aug 31.
- Individual participant dataSharing planned: Undecided
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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.
Jian Zhang study chair
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAEST16001 in people with Liver Cancer Stage IV and Gastric Cancer Stage IV, run by Zhujiang Hospital 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 14 inclusion and 18 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: finished, as of the sponsor's last update on 22 Jan 2020. 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?
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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 28 Days). 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 NCT03159585, which also lists 6 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 22 Jan 2020.