Breast CancerPhase 1/2NCT02713984
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
A Phase 1/2 study testing Anti-HER2 CAR-T in people with Breast Cancer and Ovarian Cancer, run by Zhi Yang at 1 site in China.
Trial summary
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Lung Cancer
- What is being tested?
- Anti-HER2 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Jul 2019
- 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
- Relapsed or refractory HER2 positive cancer.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Assessable lesions with a minimum size of 10mm by CT scan or MRI.
- Acceptable organ function
Show all 19Show fewer
- Hematology:
- Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
- White blood cell (WBC) (> 2000/mm^3).
- Platelet count greater than 50,000/mm^3.
- Hemoglobin greater than 9.0 g/dl.
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
- Serum creatinine less or equal to 3 times the upper limit of normal
- Total bilirubin less than or equal to 3 times the upper limit of normal.
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- Adequate cardiac function(LVEF≥40%).
- No other tumors.
- Patients volunteer to participate in the research.
Who cannot join
- Allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- MODS.
- Treated with T cell inhibitor.
- HIV affected.
- Other situations improper for the research.
Trial locations and contacts
1 site in 1 country.
China1 site
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.
- Conditions
- Breast Cancer, Ovarian Cancer, Lung Cancer, Gastric Cancer, Colorectal Cancer, Glioma
- Being tested
- Anti-HER2 CAR-T
- Keywords
- HER2 CAR-T, safety, efficiency, refractory and relapsed cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Glioma, Pancreatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HER2 CAR-TBiological
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive cancers | Experimental | Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells Receives: Biological: Anti-HER2 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 3 years
Secondary outcomes (3)
Survival time of Anti-HER2 CAR T cells in vivo.
Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.
Measured: 1 year
Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells
Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria（iRECIST）.
Measured: 12 weeks
Maximum tolerated dose (MTD) of HER2 targeted CAR T cells
Determine the maximum tolerated dose of each participant through the grades of side effects.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: Reform CAR structure due to safety consideration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi Yang, Southwest Hospital, China
- Investigators
- Cheng Qian, MD,PhD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713984
- Sponsor's protocol ID
- TMMU-BTC-005
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
- ClinicalTrials.gov ID
- NCT02713984
- Acronym / sponsor ID
- TMMU-BTC-005
- Conditions
- Breast Cancer, Ovarian Cancer, Lung Cancer, Gastric Cancer, Colorectal Cancer, Glioma
- Keywords
- HER2 CAR-T, safety, efficiency, refractory and relapsed cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reform CAR structure due to safety consideration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhi YangUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Mar 2016 (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.
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 positive cancers | Experimental | Biological: Anti-HER2 CAR-TPatients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Relapsed or refractory HER2 positive cancer.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Assessable lesions with a minimum size of 10mm by CT scan or MRI.
Key exclusion criteria (7 listed)
- Allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- MODS.
- Treated with T cell inhibitor.
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 |
|---|---|---|
| Anti-HER2 CAR-THER-2-targeting CAR-T cells infusion in HER2 positive cancers | Biological | HER2 positive cancers |
Primary outcome
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time frame: 3 years
Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 secondary outcomes
Survival time of Anti-HER2 CAR T cells in vivo.
Time frame: 1 year
Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells
Time frame: 12 weeks
Maximum tolerated dose (MTD) of HER2 targeted CAR T cells
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- 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.
Cheng Qian, MD,PhD principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-HER2 CAR-T in people with Breast Cancer and Ovarian Cancer, run by Zhi Yang 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 19 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Mar 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. (time frame: 3 years). 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 19 Mar 2020.