Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases

NCT03818165 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: SOR-CART-CEA-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Carcinoma

Keywords

pancreatic carcinoma; Cacinomaembryonic antigen postive (CEA +); liver metastases; pancreatic cancer; CEA; metastatic pancreatic carcinoma; metastatic pancreatic cancer; phase 1

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• Assess preliminary efficacy by radiographic response rate using Response Evaluation Criteria in Solid Tumors (RECIST)

  6 months

• Assess preliminary efficacy by metabolic response rate using PET Response Criteria in Solid Tumors (PERCIST)

  6 months

• Assess preliminary efficacy by response rate using Immune-related Response Criteria (irRC)

  6 months

• Assess preliminary efficacy by histologic response rate using pathologic response in biopsy specimens

  6 months

• Assess preliminary efficacy by serologic response rates by CEA levels

  6 months

Other Outcomes (5)

• Assess if serum cytokine levels correlate with response and/or toxicity to hepatic arterial infusions.

  6 months

• Assess if neutrophil:lymphocyte ratios correlate with response

  6 months

• Assess the persistence of CAR-T cells circulating in blood over time

  6 months

Study Arms (1)

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

Biological: CAR2 Anti-CEA CAR-T cells

Interventions

CAR2 Anti-CEA CAR-T cells BIOLOGICAL

doses will be delivered by hepatic arterial infusions using pressure enhanced delivery device (PEDD)

Also known as: Surefire Precision Infusion System, K171355

CAR2 Anti-CEA CAR-T cell

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Steven C Katz, MD

  Roger Williams Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: July 29, 2019
• Primary Completion: January 19, 2020
• Study Completion: May 21, 2021
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)