CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

NCT03682744 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 340-74
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peritoneal Carcinomatosis; Peritoneal Metastases; Colorectal Cancer; Gastric Cancer; Breast Cancer; Pancreas Cancer; Carcinoembryonic Antigen

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (8)

• Progression-Free Survival

  20 weeks

• Overall Survival

  20 weeks

• Bowel Obstruction Free Survival

  20 weeks

• Changes in Quality of Life

  20 weeks

• Response by the Peritoneal Carcinomatosis Index (PCI)

  16 weeks

Study Arms (1)

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

Biological: anti-CEA CAR-T cells

Interventions

anti-CEA CAR-T cells BIOLOGICAL

Intraperitoneal delivery of anti-CEA CAR-T cells

Also known as: Gene modified patient T cells, Designer T cells

anti-CEA CAR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Breast Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; 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

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: September 13, 2018
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

US (2)