Metastatic Pancreatic CarcinomaPhase 1AntiCEA_CARTNCT03818165
Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases
A Phase 1 study testing CAR2 Anti-CEA CAR-T cells in people with Metastatic Pancreatic Carcinoma, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Carcinoma
- What is being tested?
- CAR2 Anti-CEA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2019to 21 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have documented CEA+ pancreatic adenocarcinoma liver metastases and have failed greater than or equal to 1 line of conventional systemic therapy.
- Must have at least evaluable liver metastases.
- Must have a life-expectancy at least 12 weeks.
- Patients must be willing and able to comply with the study schedule and all other protocol requirements.
- Females of childbearing potential must have 2 negative pregnancy tests, agree to pregnancy tests during the study, and sexually active female and male patients must be willing to use an effective birth control method to avoid pregnancy.
Who cannot join
- Subjects who have received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug.
- Subjects who have received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug.
- Have any unresolved toxicity greater than Grade 2 from previous anticancer therapy.
- Have a history of confirmed metastases outside the peritoneal cavity, lungs, or liver.
- More than 50% replacement of one or both liver lobes with tumor.
- Has tumor causing biliary obstruction not amenable to stenting.
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- Have a high volume of lung or peritoneal metastases.
- Has received any CAR cell line therapies.
- Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening.
- Has untreated or ongoing intra-abdominal infection or bowel obstruction.
- Has any clinically significant elevated baseline lab results for serum creatinine, AST, and total bilirubin (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome), and alkaline phosphatase at screening regardless of causality.
- Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
- Female patients who are pregnant or breastfeeding.
- Have active bacterial, viral, or fungal infections.
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent study participation.
- Left ventricular ejection fraction (LVEF) < 40%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roger Williams Medical Center
Providence, Rhode Island, 02908
About this study
Official title: Phase 1b Study of the Efficacy and Safety of CAR2 Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases Resistant to Standard Therapy Using the HITM Method and Pressure Enabled Delivery Device
This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria.
Read the detailed description
Patients will receive weekly 3 doses of CAR2 Anti-CEA CAR-T cells in each 28-day cycle by hepatic arterial infusions using a Pressure Enhanced Delivery Device (PEDD) with low dose systemic IL-2 support. Patients may receive up to 3 cycles of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions, per discretion of the investigator.
All patients who receive investigational CAR-T therapy will be included in the analyses and summaries of safety, efficacy, pharmacokinetic, and pharmacodynamic assessments.
- Conditions
- Metastatic Pancreatic Carcinoma
- Being tested
- CAR2 Anti-CEA CAR-T cells
- Keywords
- pancreatic carcinoma, Cacinomaembryonic antigen postive (CEA +), liver metastases, pancreatic cancer, CEA, metastatic pancreatic carcinoma, metastatic pancreatic cancer, phase 1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR2 Anti-CEA CAR-T cellsBiological
Also called Surefire Precision Infusion System, K171355
doses will be delivered by hepatic arterial infusions using pressure enhanced delivery device (PEDD)
| Study group | Role | What they receive |
|---|---|---|
| CAR2 Anti-CEA CAR-T cell | Experimental | 3 doses of CAR2 Anti-CEA CAR-T cells for each cycle; up to 3 additional cycles received per investigator discretion Receives: Biological: CAR2 Anti-CEA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess preliminary efficacy by overall survival
As a measure of activity, Overall Survival (OS) will be assessed. The events for the assessment of OS are death events. Time to event endpoints will be estimated using Kaplan-Meier methods. Point estimates and 95% confidence intervals will be provided where applicable.
Measured: 6 months
Secondary outcomes (8)
Assess preliminary efficacy by radiographic response rate using Response Evaluation Criteria in Solid Tumors (RECIST)
As a measure of activity, overall response rate will be assessed by radiographic scans using RECIST criteria. Response will be assessed for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by metabolic response rate using PET Response Criteria in Solid Tumors (PERCIST)
As a measure of activity, overall response rate will be assessed by radiographic scans using PERCIST criteria. Response will be assessed for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by response rate using Immune-related Response Criteria (irRC)
As a measure of activity, overall response rate will be assessed by radiographic scans using irRC. Response will be assessed for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by histologic response rate using pathologic response in biopsy specimens
As a measure of activity, overall response rate will be assessed by pathologic criteria using biopsies of the liver metastases and measuring necrosis and fibrosis. REsponse rates will be assess for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by serologic response rates by CEA levels
As a measure of activity, overall response rate will be assessed by serologic CEA levels. Response will be assess for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by serologic response rates by CA 19-9 levels
As a measure of activity, overall response rate will be assessed by serologic CA 19-9 levels. Response will be assess for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by duration of response in accordance with RECIST criteria
As a measure of activity, duration of response will be measured using radiologic scans and assessed according to RECIST criteria. This will be assess for each patient over a 6-month timeframe during the treatment and observation phases of the protocol.
Measured: 6 months
Assess preliminary efficacy by in-liver progression free survival (PFS)
As a measure of activity, in-liver PFS will be assessed. The events for the assessment of PFS are disease progression and death events. This time to event endpoint will be estimated using Kaplan-Meier methods. Point estimate estimates and 95% confidence intervals will be provided where appropriate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start29 Jul 2019
- Primary completion19 Jan 2020
- Study completion21 May 2021
Why it stopped: Limited enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CarcinomaStudies 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
- Model description
- Three doses of CAR2 Anti-CEA CAR T Cells 1 x 10e10 cells by hepatic artery infusion (on Days 1, 8, and 15) of each 28-day cycle in the Treatment Period using the HITM method and Surefire device, with IL-2 systemic infusion. Patient may receive up to three 28-day cycles of CAR-T therapy in the Treatment Period.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven C Katz, MD, Principal investigator, Roger Williams Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818165
- Sponsor's protocol ID
- SOR-CART-CEA-001
- Acronym
- AntiCEA_CART
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of the Efficacy and Safety of CAR2 Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases Resistant to Standard Therapy Using the HITM Method and Pressure Enabled Delivery Device
- ClinicalTrials.gov ID
- NCT03818165
- Acronym / sponsor ID
- AntiCEA_CART / SOR-CART-CEA-001
- Conditions
- Metastatic Pancreatic Carcinoma
- Keywords
- pancreatic carcinoma, Cacinomaembryonic antigen postive (CEA +), liver metastases, pancreatic cancer, CEA, metastatic pancreatic carcinoma, metastatic pancreatic cancer, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 19 Jan 2020 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 28 Jan 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 study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria.
Detailed description
Patients will receive weekly 3 doses of CAR2 Anti-CEA CAR-T cells in each 28-day cycle by hepatic arterial infusions using a Pressure Enhanced Delivery Device (PEDD) with low dose systemic IL-2 support. Patients may receive up to 3 cycles of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions, per discretion of the investigator.
All patients who receive investigational CAR-T therapy will be included in the analyses and summaries of safety, efficacy, pharmacokinetic, and pharmacodynamic assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three doses of CAR2 Anti-CEA CAR T Cells 1 x 10e10 cells by hepatic artery infusion (on Days 1, 8, and 15) of each 28-day cycle in the Treatment Period using the HITM method and Surefire device, with IL-2 systemic infusion. Patient may receive up to three 28-day cycles of CAR-T therapy in the Treatment Period.
| Arm | Type | Receives |
|---|---|---|
| CAR2 Anti-CEA CAR-T cell | Experimental | Biological: CAR2 Anti-CEA CAR-T cells3 doses of CAR2 Anti-CEA CAR-T cells for each cycle; up to 3 additional cycles received per investigator discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have documented CEA+ pancreatic adenocarcinoma liver metastases and have failed greater than or equal to 1 line of conventional systemic therapy.
- Must have at least evaluable liver metastases.
- Must have a life-expectancy at least 12 weeks.
- Patients must be willing and able to comply with the study schedule and all other protocol requirements.
- Females of childbearing potential must have 2 negative pregnancy tests, agree to pregnancy tests during the study, and sexually active female and male patients must be willing to use an effective birth control method to avoid pregnancy.
Key exclusion criteria (16 listed)
- Subjects who have received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug.
- Subjects who have received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug.
- Have any unresolved toxicity greater than Grade 2 from previous anticancer therapy.
- Have a history of confirmed metastases outside the peritoneal cavity, lungs, or liver.
- More than 50% replacement of one or both liver lobes with tumor.
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 |
|---|---|---|
| CAR2 Anti-CEA CAR-T cellsAlso: Surefire Precision Infusion System, K171355doses will be delivered by hepatic arterial infusions using pressure enhanced delivery device (PEDD) | Biological | CAR2 Anti-CEA CAR-T cell |
Primary outcome
Assess preliminary efficacy by overall survival
Time frame: 6 months
As a measure of activity, Overall Survival (OS) will be assessed. The events for the assessment of OS are death events. Time to event endpoints will be estimated using Kaplan-Meier methods. Point estimates and 95% confidence intervals will be provided where applicable.
8 secondary outcomes
Assess preliminary efficacy by radiographic response rate using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 6 months
Assess preliminary efficacy by metabolic response rate using PET Response Criteria in Solid Tumors (PERCIST)
Time frame: 6 months
Assess preliminary efficacy by response rate using Immune-related Response Criteria (irRC)
Time frame: 6 months
Assess preliminary efficacy by histologic response rate using pathologic response in biopsy specimens
Time frame: 6 months
Assess preliminary efficacy by serologic response rates by CEA levels
Time frame: 6 months
Assess preliminary efficacy by serologic response rates by CA 19-9 levels
Time frame: 6 months
Assess preliminary efficacy by duration of response in accordance with RECIST criteria
Time frame: 6 months
Assess preliminary efficacy by in-liver progression free survival (PFS)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Limited enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
Steven C Katz, MD principal investigator
Roger Williams Medical Center
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 CAR2 Anti-CEA CAR-T cells in people with Metastatic Pancreatic Carcinoma, run by Sorrento Therapeutics, Inc. at 1 site in United States.
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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 Jan 2023. 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 United States. 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 was stopped early (reason given: Limited enrollment.). Results are not available in the source record.
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?
Assess preliminary efficacy by overall survival (time frame: 6 months). 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 17 Jan 2023.