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A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 \[LGR5\]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer. Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5. Participants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing.
Participants will receive a single Intravenous dose of CNA3103. Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage. Participants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event/s, death or withdrawal of consent.
Study details:
This is a Phase 1/2a, multicenter, open-label study in adult subjects with metastatic colorectal cancer. (CRC). The study will consist of 2 segments:.
Phase 1 Segment (Dose Escalation): a Bayesian Optimal Interval (BOIN) study design will be used to minimize any risks of exposure to the novel CNA3103 CAR-T cells during dose escalation while determining the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). A minimum of 3 subjects per cohort will be enrolled at each dose level, with appropriate staggering of subjects within and between dose levels. Phase 2a Segment (Dose Expansion): After determination of the MTD/RP2D, additional subjects will be enrolled and treated with CNA3103 at that dose to further assess the safety, PK, pharmacodynamic, and anti-tumor properties of CNA3103.
Based upon safety data of these additional subjects, the Sponsor, in consult with the Investigators, may choose to enroll additional subjects at the same or a different dose.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-24
Primary completion: 2027-12-01
Study completion finish: 2027-12-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05759728
Intervention or treatment
BIOLOGICAL: CNA3103: 5 x 10^7 cells
BIOLOGICAL: CNA3103: 1.5 x 10^8 cells
BIOLOGICAL: CNA3103: 4.5 x 10^8 cells
BIOLOGICAL: CNA3103: 1.5 x 10^9 cells
BIOLOGICAL: CNA3103: 2.5 x 10^7 cells
Conditions
- • Colorectal Cancer Metastatic
Find a site
Closest Location:
Carina Biotech Investigators
Research sites nearby
Select from list below to view details:
Carina Biotech Investigators
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: CNA3103 Monotherapy
| BIOLOGICAL: CNA3103: 5 x 10^7 cells
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To determine the safety of treatment with CNA3103. | Incidence of Treatment-Emergent Adverse Events | 24 Months |
To determine the overall best response to CNA3103. | Best response per Response Evaluation Criteria in Solid Tumors (RECIST). | 24 Months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To determine the recommended Phase 2a dose (RP2D) of CNA3103 | Determined by dose limiting toxicities (DLTs) | 28 days |
To monitor for replication competent viral construct in blood specimens | Viral construct presence will be monitored | 24 Months |
To determine the Pharmacokinetics of CNA3103 | Levels of CNA3103 cells measured | 24 Months |
To determine overall survival | Survival will be calculated from the onset of CNA3103 therapy. | 24 Months |
Failure to treat | Caused by manufacturing issues or patient related issues. | 8 Weeks |
To determine progression-free survival | Calculated from the onset of therapy to disease progression. | 24 months |
Frequently Asked Questions
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