Peritoneal CarcinomatosisPhase 1NCT03682744
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
A Phase 1 study testing anti-CEA CAR-T cells in people with Peritoneal Carcinomatosis and Peritoneal Metastases, run by Sorrento Therapeutics, Inc. at 2 sites in United States.
Trial summary
This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer
- What is being tested?
- 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
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2018to Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Must have documented CEA+ carcinomatosis or malignant ascites as demonstrated by an elevated serum CEA level (≥ 10 ng/mL) or immunohistochemistry on a biopsy or cytologic specimen (archived tissue is acceptable), for determination of CEA expression. Primary tumor may be intact and limited liver and/or lung disease permitted.
- Must have at least evaluable disease by physical examination, serum tumor markers, radiologic assessment, tumor markers, or laparoscopic visual assessment.
- Have a life-expectancy ≥ 12 weeks and ECOG performance status ≤ 2.
- May have low volume of liver metastases defined as < 50% replacement of the liver volume by metastatic disease, as long as all other eligibility criteria are satisfied.
- Be willing and able to comply with the study schedule and all other protocol requirements.
Who cannot join
- Female patients of childbearing age will be tested for pregnancy. Pregnant patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control.
- Received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug. Exceptions may be granted with medical monitor approval.
- Received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug. Exceptions may be granted with medical monitor approval.
- Have any unresolved toxicity > Grade 2 from previous anticancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve.
- Have a history of histologically confirmed metastases outside the peritoneal cavity, lungs, or liver.
- Have high volume lung or liver metastases, defined as >5 lung lesions greater than 1 cm in size or ≥ 50% replacement the liver volume by metastatic disease.
Show all 21Show fewer
- Received CAR-T, CAR-T cell line, CAR-NK, CAR-pNK, or CAR-NK cell line therapies.
- Have any of the following laboratory results at Screening (Screening volumes must be independent of blood product treatment):
- Hemoglobin ≤ 8.0 g/dL
- Platelet count < 50 × 109/L
- Absolute neutrophil count (ANC) < 1.0 × 109/L
- Untreated or ongoing intra-abdominal infection or bowel obstruction.
- Have any of the following laboratory results at Screening, regardless of causality:
- Serum creatinine ≥ 3.0, or estimated creatinine clearance ≤ 30 mL/min and not dialysis dependent
- Aspartate aminotransferase (AST) ≥ 4 × upper limit of normal (ULN) and total bilirubin ≥ 2.0 mg/dL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome).
- Have human immunodeficiency virus (HIV) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia, or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBsAg positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test.
- Are pregnant or breastfeeding.
- Have active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection.
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
- Has any condition, including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study.
- Left ventricular ejection fraction (LVEF) < 40%
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Roger Williams Medical Center
Providence, Rhode Island, 02908
About this study
Official title: Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites
This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
Read the detailed description
Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by intraperitoneal infusion at specific cell doses. One anti-CEA CAR-T dose per patient is planned. Additional cycles may be administered at the discretion of the principal investigator. Normal peritoneal and tumor biopsies will be obtained at the time of the CAR-T infusion, on the final day of the treatment period, and during reporting interval #3.
- Conditions
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Gastric Cancer, Breast Cancer, Pancreas Cancer
- Being tested
- anti-CEA CAR-T cells
- Medical subject headings
- Peritoneal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CEA CAR-T cellsBiological
Also called Gene modified patient T cells, Designer T cells
Intraperitoneal delivery of anti-CEA CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| anti-CEA CAR-T cells | Experimental | One intraperitoneal infusion of gene-modified anti-CEA T cells are administered to patients with CEA-expressing peritoneal metastases or malignant ascites Receives: Biological: anti-CEA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events
To determine the safety and maximum tolerated dose (MTD) following intraperitoneal infusion(s) of anti-CEA CAR-T cells for inoperable CEA+ peritoneal metastases or malignant ascites.
Measured: 16 weeks
Secondary outcomes (8)
Progression-Free Survival
As a measure of activity, Progression-free survival (PFS) will be assessed. The events for the assessment of PFS are disease progression and death events
Measured: 20 weeks
Overall Survival
As a measure of activity, Overall Survival (OS) will be assessed. The events for the assessment of OS are death events.
Measured: 20 weeks
Bowel Obstruction Free Survival
Measuring the time frame in which a patient does not experience a bowel obstruction
Measured: 20 weeks
Changes in Quality of Life
Changes in quality of life measured by Quality of Life Index (IQI) survey pre and post-treatment
Measured: 20 weeks
Response by the Peritoneal Carcinomatosis Index (PCI)
Direct visualization of tumor burden assessment by the PCI pre and post-treatment
Measured: 16 weeks
Radiographic treatment response by MRI
Changes in tumor size
Measured: 20 weeks
Radiographic treatment response by PET
Changes in tumor metabolic activity
Measured: 20 weeks
Serologic response rates
Measurement of CEA and CA19-9
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start13 Sep 2018
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Unable to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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
- 0 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
- NCT03682744
- Sponsor's protocol ID
- 340-74
- Status last verified
- Mar 2022
- First submitted
- 21 Sep 2018
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites
- ClinicalTrials.gov ID
- NCT03682744
- Acronym / sponsor ID
- 340-74
- Conditions
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Gastric Cancer, Breast Cancer, Pancreas Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 25 Sep 2018 (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 an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
Detailed description
Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by intraperitoneal infusion at specific cell doses. One anti-CEA CAR-T dose per patient is planned. Additional cycles may be administered at the discretion of the principal investigator. Normal peritoneal and tumor biopsies will be obtained at the time of the CAR-T infusion, on the final day of the treatment period, and during reporting interval #3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CEA CAR-T cells | Experimental | Biological: anti-CEA CAR-T cellsOne intraperitoneal infusion of gene-modified anti-CEA T cells are administered to patients with CEA-expressing peritoneal metastases or malignant ascites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Must have documented CEA+ carcinomatosis or malignant ascites as demonstrated by an elevated serum CEA level (≥ 10 ng/mL) or immunohistochemistry on a biopsy or cytologic specimen (archived tissue is acceptable), for determination of CEA expression. Primary tumor may be intact and limited liver and/or lung disease permitted.
- Must have at least evaluable disease by physical examination, serum tumor markers, radiologic assessment, tumor markers, or laparoscopic visual assessment.
- Have a life-expectancy ≥ 12 weeks and ECOG performance status ≤ 2.
- May have low volume of liver metastases defined as < 50% replacement of the liver volume by metastatic disease, as long as all other eligibility criteria are satisfied.
Key exclusion criteria (21 listed)
- Female patients of childbearing age will be tested for pregnancy. Pregnant patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control.
- Received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug. Exceptions may be granted with medical monitor approval.
- Received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug. Exceptions may be granted with medical monitor approval.
- Have any unresolved toxicity > Grade 2 from previous anticancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve.
- Have a history of histologically confirmed metastases outside the peritoneal cavity, lungs, or liver.
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-CEA CAR-T cellsAlso: Gene modified patient T cells, Designer T cellsIntraperitoneal delivery of anti-CEA CAR-T cells | Biological | anti-CEA CAR-T cells |
Primary outcome
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events
Time frame: 16 weeks
To determine the safety and maximum tolerated dose (MTD) following intraperitoneal infusion(s) of anti-CEA CAR-T cells for inoperable CEA+ peritoneal metastases or malignant ascites.
8 secondary outcomes
Progression-Free Survival
Time frame: 20 weeks
Overall Survival
Time frame: 20 weeks
Bowel Obstruction Free Survival
Time frame: 20 weeks
Changes in Quality of Life
Time frame: 20 weeks
Response by the Peritoneal Carcinomatosis Index (PCI)
Time frame: 16 weeks
Radiographic treatment response by MRI
Time frame: 20 weeks
Radiographic treatment response by PET
Time frame: 20 weeks
Serologic response rates
Time frame: 20 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 6 Apr 2022.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-CEA CAR-T cells in people with Peritoneal Carcinomatosis and Peritoneal Metastases, run by Sorrento Therapeutics, Inc. at 2 sites 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 6 inclusion and 21 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events (time frame: 16 weeks). 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 6 Apr 2022.