GCC19CART for Patients With Metastatic Colorectal Cancer (CARAPIA-1)

Innovative Cellular Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: GCC19CART

Study type: Interventional

Funder types: Industry

Identifiers

NCT05319314

ICT-GCC19CART-US-001

Details and patient eligibility

About

Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults > 18 years old
• 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

• Subjects with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive track, urinary bladder, or blood vessel) with GCC19CART therapy.
• 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

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

GCC19CART

Experimental group

Description:

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.

Treatment:

Drug: GCC19CART