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RecruitingLast updated: 3 November 2023

This study aims to determine how safe and effective a new immunotherapy is in people with metastatic colorectal cancerA Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer

Clinical summary

Summary

This study has two segments: Phase 1 (Dose Escalation) and Phase 2a (Dose Exapnsion).

In Phase 1 (Dose Escalation) participants will be enrolled to receive escalating doses of the investigational immunothreapy (called CNA3103) to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).

In Phase 2a (Dose Expansion) additional participants will be enrolled and treated with CNA3103 at the MTD/RP2D to further assess the safety and effectivenss of the drug.

CNA3103 will be administered as an intravenous (IV) infusion.

Conditions

This trial is treating patients with metastatic bowel cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Carina Biotech Limited

Scientific Title

A Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer

Eligibility

Inclusion

  • Signed written Informed Consent.
  • Male and female subjects aged greater than or equal to18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score 0 to 1.
  • Histologically or cytologically confirmed metastatic colorectal cancer previously treated with 5-FU, oxaliplatin and irinotecan-based regimens for metastatic disease and least 4 weeks from last chemotherapy, biologic, radiotherapy, or investigational therapy, with resolution of all lingering toxicities to Grade <1, with the exception of neuropathy and alopecia.
  • Positive for any level of LGR5 expression in tumor biopsies.
  • Measurable or evaluable disease per RECIST version 1.1 .
  • Life expectancy of at least >12 weeks.
  • Normal organ and marrow function.
  • No clinically significant abnormalities in urinalysis results at Screening.
  • No known clinically significant gastrointestinal disease within 28 days prior to beginning study treatment.
  • No ongoing requirement for anti-diarrheal therapy.
  • For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement (by subject and/or partner) to use a highly effective form of contraception and to continue its use for 6 months after the last dose of IP.
  • Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to CNA3103 administration.

Exclusion

  • Inability to comply with study and follow-up procedures.
  • Women who are pregnant or lactating.
  • Has BRAF-mutated colorectal cancer.
  • Has received any third line treatment regimen or received trifluridine/tipiracil (TAS-102) and regorafenib for metastatic disease.
  • Treatment with chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks before initiation of study treatment.
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent in the previous 28 days.
  • Have received antibody-based therapies within the previous 28 days or 5 half-lives of the agent, whichever is shorter.
  • Major surgery, other than diagnostic surgery, in the previous 4 weeks.
  • Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry.
  • Any uncontrolled medical or psychiatric risk factors which would contraindicate the use or impair the ability of the subject to provide informed consent, receive protocol therapy or may impose excessive risk to the subject.
  • Known central nervous system (CNS) disease.
  • Current use of medications that may have the potential of QTc prolongation.
  • Uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
  • Has a known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, alcoholic or other hepatitis, or cirrhosis.
  • Inability to be venipunctured and/or tolerate venous access.
  • Second malignancies within 5 years prior to enrollment, except for those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent.
  • Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of ≤10 mg/day prednisone.
  • History of inflammatory bowel disease (active or past) or active peptic ulcer disease.
  • History of connective tissue disorders.
  • History of chronic leukemias.
  • History of previous, whole abdomen radiation therapy (or total pelvic radiation therapy) or more than Grade 1 residual toxicity from previous radiation therapy.
  • High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year
  • Left ventricular ejection fraction <50%.
  • Have had a venous thromboembolic event requiring anticoagulation.
  • Congenital or acquired long QT syndrome.
  • QTc prolongation.
  • History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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