GCC19CART for Patients With Metastatic Colorectal Cancer
NCT ID: NCT05319314
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2022-08-01
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
NCT06462183
Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
NCT00005085
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
NCT05198934
An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)
NCT01775644
A Study of JNJ-89402638 for Metastatic Colorectal Cancer
NCT06663319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GCC19CART
Single infusion of GCC19CART at the dose assigned to an individual subject.
All subjects will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner.
Two dose level escalations are planned with one dose de-escalation listed if needed.
GCC19CART
Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GCC19CART
Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical and histopathological diagnosis of metastatic colorectal cancer
* Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC). Positivity on staining of archival tumor tissue is adequate.
* Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
* No surgical options with curative intent.
* Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy.
* Have at least one extracranial measurable target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.
Exclusion Criteria
* No active infectious diseases or comorbid conditions that would interfere with safety or data quality.
* Subjects with active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or subjects with unexplained fever (temperature \> 38.1˚C) within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of investigational product administration.
* Pregnant or breast-feeding women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovative Cellular Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICT-GCC19CART-US-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.