Advanced HER-2 Positive Solid TumorsPhase 1/2CART-HER-2NCT01935843
Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors
A Phase 1/2 study testing CART-HER-2 in people with Advanced HER-2 Positive Solid Tumors and Chemotherapy Refactory, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory, HER-2 Antibody Inhibitor Therapy Refactory
- What is being tested?
- CART-HER-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Sep 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy refractory HER-2-positive breast cancer, gastric cancer, non-small cell lung cancer, and chemotherapy resistant or relapsed ovary cancer.
- Relapsed patients after anti-HER-2 using antibody or kinase inhibitor therapy.
- Patients must be 18 years of age or older.
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
- Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
- Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
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- Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
- Seronegative for HIV antibody.
- Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
- Patients must be willing to sign an informed consent.
Who cannot join
- Patients with life expectancy less than 12 months will be excluded.
- Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- Pregnant and/or lactating women will be excluded.
- Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
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- Patients with any type of primary immunodeficiencies will be excluded from the study.
- Patients requiring corticosteroids (other than inhaled) will be excluded.
- Patients with history of T cell tumors will be excluded.
- Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, Dr., +86-10-13811421950, hanwdrsw@sina.com
Yao Wang, Dr.
About this study
Official title: Clinical Study of Chimeric HER-2 Antigen Receptor-modified T Cells in Chemotherapy Refractory HER-2 Advanced Solid Tumors
RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric cancer, hepatic carcinoma, endometrial cancer and ovary cancer.
Read the detailed description
PRIMARY OBJECTIVES:
I.Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with anti-HER-2 vector(referred to as CART-HER-2 cells).
II.Determine duration of in vivo survival of CART-HER-2 cells. RT-PCR(reverse transcription polymerase chain reaction)analysis of whole blood will be used to detect and quantify survival of CART-HER-2 TCR zeta:CD137 and TCR(T-cell receptor) zeta cells over time.
SECONDARY OBJECTIVES:
I.For patients with detectable diseases, measure anti-tumor response due to CART-HER-2 cell infusions.
II.Estimate relative trafficking of CART-HER-2 cells in tumor bed.
III.Determine if cellular or humoral host immunity develops against the murine anti-HER-2, and assess correlation with loss of detectable CART-HER-2(loss of engraftment).
IV.Determine the relative subsets of CART-HER-2 T cells (Tcm,Tem,and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-HER-2-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
Estimate relative trafficking of CART-HER-2 cells in peripheral blood.
- Conditions
- Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory, HER-2 Antibody Inhibitor Therapy Refactory
- Being tested
- CART-HER-2
- Keywords
- CART-HER-2, HER-2 positive, Advanced, Refactory, Solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-HER-2Biological
| Study group | Role | What they receive |
|---|---|---|
| Anti-tumor responses of CART-HER-2 | Experimental | Not described Receives: Biological: CART-HER-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Study related adverse events
Measured: Until week 24
Secondary outcomes (1)
Anti-leukemia response to CART-HER-2 cell infusions
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced HER-2 Positive Solid TumorsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, Dr., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935843
- Sponsor's protocol ID
- CHN-PLAGH-BT-009
- Acronym
- CART-HER-2
- Status last verified
- Jan 2016
- First submitted
- 1 Sep 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feng K, Liu Y, Guo Y, Qiu J, Wu Z, Dai H, Yang Q, Wang Y, Han W. Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers. Protein Cell. 2018 Oct;9(10):838-847. doi: 10.1007/s13238-017-0440-4. Epub 2017 Jul 14.
PubMed 28710747
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Chimeric HER-2 Antigen Receptor-modified T Cells in Chemotherapy Refractory HER-2 Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01935843
- Acronym / sponsor ID
- CART-HER-2 / CHN-PLAGH-BT-009
- Conditions
- Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory, HER-2 Antibody Inhibitor Therapy Refactory
- Keywords
- CART-HER-2, HER-2 positive, Advanced, Refactory, Solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 5 Sep 2013 (estimated)
- 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.
RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric cancer, hepatic carcinoma, endometrial cancer and ovary cancer.
Detailed description
PRIMARY OBJECTIVES:
I.Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with anti-HER-2 vector(referred to as CART-HER-2 cells).
II.Determine duration of in vivo survival of CART-HER-2 cells. RT-PCR(reverse transcription polymerase chain reaction)analysis of whole blood will be used to detect and quantify survival of CART-HER-2 TCR zeta:CD137 and TCR(T-cell receptor) zeta cells over time.
SECONDARY OBJECTIVES:
I.For patients with detectable diseases, measure anti-tumor response due to CART-HER-2 cell infusions.
II.Estimate relative trafficking of CART-HER-2 cells in tumor bed.
III.Determine if cellular or humoral host immunity develops against the murine anti-HER-2, and assess correlation with loss of detectable CART-HER-2(loss of engraftment).
IV.Determine the relative subsets of CART-HER-2 T cells (Tcm,Tem,and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-HER-2-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
Estimate relative trafficking of CART-HER-2 cells in peripheral blood.
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 responses of CART-HER-2 | Experimental | Biological: CART-HER-2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chemotherapy refractory HER-2-positive breast cancer, gastric cancer, non-small cell lung cancer, and chemotherapy resistant or relapsed ovary cancer.
- Relapsed patients after anti-HER-2 using antibody or kinase inhibitor therapy.
- Patients must be 18 years of age or older.
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
- Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
Key exclusion criteria (10 listed)
- Patients with life expectancy less than 12 months will be excluded.
- Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- Pregnant and/or lactating women will be excluded.
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 |
|---|---|---|
| CART-HER-2 | Biological | Anti-tumor responses of CART-HER-2 |
Primary outcome
Occurrence of Study related adverse events
Time frame: Until week 24
1 secondary outcome
Anti-leukemia response to CART-HER-2 cell infusions
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 28710747Feng K, Liu Y, Guo Y, Qiu J, Wu Z, Dai H, Yang Q, Wang Y, Han W. Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers. Protein Cell. 2018 Oct;9(10):838-847. doi: 10.1007/s13238-017-0440-4. Epub 2017 Jul 14.
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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.
Weidong Han, Dr. study chair
Chinese PLA General Hospital
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 CART-HER-2 in people with Advanced HER-2 Positive Solid Tumors and Chemotherapy Refactory, run by Chinese PLA General 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 11 inclusion and 10 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 28 Jan 2016. 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 Weidong Han, Dr. (+86-10-13651392893, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Study related adverse events (time frame: Until week 24). 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 NCT01935843, which also lists 1 linked publication.
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 28 Jan 2016.