Pancreatic CancerPhase 1NCT05605197
U87 CART in Treatment of Advanced Solid Tumor
A Phase 1 study testing U87 CAR-T in people with Pancreatic Cancer and Solid Tumor, Adult, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial summary
This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Solid Tumor, Adult
- What is being tested?
- U87 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 8 Oct 2025
- 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
- Voluntary informed consent is given;
- Age 18 to 75;
- Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy;
- Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%);
- Expected survival ≥12 weeks;
- Measurable tumor lesions according to RECIST 1.1;
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- ECOG performance score 0-1;
- Sufficient venous access for mononuclear cell collection;
- HBc Ab positive, HBsAg negative can be included in the group when the PCR detection of HBV DNA is negative;
- Patients should maintain adequate organ function;
- Dyspnea (CTCAE v5.0) ≤ Grade 1; Blood oxygen saturation>91% without oxygen inhalation;
- Pregnancy test was negative in women of childbearing age; Both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year;
Who cannot join
- Pregnant or lactating women;
- Uncontrolled active infections;
- Active Syphilis, HIV, hepatitis B or hepatitis C infection;
- Congenital immunodeficiency;
- Have serious allergic reaction to any drug to be used in this study;
- Other incurable malignant tumors in the past three years;
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- History or presence of clinically relevant CNS pathology such as epilepsy, Cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease;
- Have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases;
- Subjects requiring anticoagulation or long-term antiplatelet therapy;
- Subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study.
- Other situations that the investigator thinks are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
Shilong Han, doctor contact
China1 site, 1 recruiting
- Recruiting
China Shanghai 10th People's Hospital
Shanghai
Li mao quan, doctor, 021-66300114 ext. 3506, cjr.limaoquan@vip.163.com
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor
This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .
Read the detailed description
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
- Conditions
- Pancreatic Cancer, Solid Tumor, Adult
- Being tested
- U87 CAR-T
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U87 CAR-TDrug
Subjects will be pretreated with cyclophosphamide 250~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3~6 patients.
| Study group | Role | What they receive |
|---|---|---|
| U87 CAR-T cells | Experimental | The Patients are enrolled into 2 dose level cohorts in sequence Receives: Drug: U87 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Dose-limiting toxicity after U87 CAR-T cells infusion.
Measured: 28 days post administration of CAR-T-cells
Secondary outcomes (9)
Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Disease control rate: including CR, PR and SD(Assessed based on RECIST 1.1 criteria)
Measured: 2 years post CAR T cell infusion
Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Objective response rate includes：CR、PR(Assessed based on RECIST1.1 criteria)
Measured: 2 years post CAR T cell infusion
Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness]
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
Measured: 2 years post CAR T cell infusion
Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness]
PFS will be assessed from the first U87 CAR-T cells infusion to death from any cause or the first assessment of progression(Assessed based on RECIST1.1 ） criteria)
Measured: 2 years post CAR T cell infusion
Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness]
OS will be assessed from the first U87 CAR-T cells infusion to death from any cause (Assessed based on RECIST 1.1 criteria)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Peak value of eripheral blood (Cmax)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Area under the eripheral blood concentration versus time curve (AUC)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time of peak value
Measured: 2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, IL-2, TNFα, ferritin and CRP at each time point
Measured: 2 years post CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start19 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605197
- Sponsor's protocol ID
- U87-3
- Status last verified
- Nov 2023
- First submitted
- 3 Oct 2022
- Last updated
- 28 May 2024
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05605197
- Acronym / sponsor ID
- U87-3
- Conditions
- Pancreatic Cancer, Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 4 Nov 2022 (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-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .
Detailed description
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U87 CAR-T cells | Experimental | Drug: U87 CAR-TThe Patients are enrolled into 2 dose level cohorts in sequence |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary informed consent is given;
- Age 18 to 75;
- Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy;
- Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%);
- Expected survival ≥12 weeks;
Key exclusion criteria (11 listed)
- Pregnant or lactating women;
- Uncontrolled active infections;
- Active Syphilis, HIV, hepatitis B or hepatitis C infection;
- Congenital immunodeficiency;
- Have serious allergic reaction to any drug to be used in this study;
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 |
|---|---|---|
| U87 CAR-TSubjects will be pretreated with cyclophosphamide 250~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3~6 patients. | Drug | U87 CAR-T cells |
Primary outcome
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days post administration of CAR-T-cells
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Dose-limiting toxicity after U87 CAR-T cells infusion.
9 secondary outcomes
Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Time frame: 2 years post CAR T cell infusion
Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Time frame: 2 years post CAR T cell infusion
Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness]
Time frame: 2 years post CAR T cell infusion
Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness]
Time frame: 2 years post CAR T cell infusion
Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness]
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- 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.
Shilong Han, doctor contact
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 U87 CAR-T in people with Pancreatic Cancer and Solid Tumor, Adult, run by Shanghai Unicar-Therapy Bio-medicine Technology 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 12 inclusion and 11 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 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maoquan Li, doctor (021-66300114*3506, cjr.limaoquan@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days post administration of CAR-T-cells). 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 28 May 2024.