ITIL-306 for Advanced Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Instil Bio

Disqualifiers: Other malignancy, Cardiac disease, CNS disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and potential of a new cell therapy, ITIL-306, for individuals with advanced solid tumors unresponsive to standard treatments. ITIL-306 employs a person's own immune cells to combat cancer, particularly when the cancer exhibits a marker called folate receptor α. The trial includes individuals with specific types of ovarian, lung, and kidney cancers. It is best suited for those whose cancer has worsened after treatments like chemotherapy. Participants must also be able to undergo surgical removal of a tumor for cell collection. As a Phase 1 trial, this research aims to understand how ITIL-306 functions in people, offering participants the chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ITIL-306 is likely to be safe for humans?

Research has shown that ITIL-306 is currently being tested for safety in humans, as it is in the early stages of clinical trials. Scientists are beginning to assess how well people tolerate it and what side effects might occur.

ITIL-306 is a type of cell therapy made from a person's own immune cells, extracted from their tumor. These cells are then modified to enhance their ability to fight cancer. Specific safety data is limited, but early trials are designed to monitor any negative effects closely.

As ITIL-306 remains in early trials, doctors and researchers are closely observing patient reactions to different doses. This careful monitoring ensures the treatment remains as safe as possible while they gather more information about its effects.

Prospective trial participants should discuss the potential risks and benefits with their doctor. This conversation can help clarify expectations and determine if participation is a suitable choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ITIL-306 because it represents a new frontier in cancer treatment by harnessing the power of the immune system. Unlike traditional chemotherapy and radiation, which attack cancer cells directly but can also harm healthy cells, ITIL-306 is designed to train the body's own immune system to recognize and fight cancer more effectively. This immunotherapy approach targets specific cancer markers, which could lead to fewer side effects and more personalized care for patients with epithelial ovarian cancer, non-small cell lung cancer, and renal cell carcinoma. These innovative strategies aim to improve outcomes and offer hope where standard treatments may fall short.

What evidence suggests that ITIL-306 might be an effective treatment for advanced cancer?

Research shows that ITIL-306 is a promising new treatment for advanced solid tumors. This treatment uses the patient's own immune cells, called tumor-infiltrating lymphocytes (TILs), extracted from their tumors. ITIL-306 includes a special molecule that activates these TILs when they encounter a specific target on the cancer, known as folate receptor α (FOLR1). The trial will test ITIL-306 in two phases: Phase 1a will involve dose escalation in participants with epithelial ovarian cancer (EOC), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Phase 1b will expand to specific cohorts for each cancer type. Although limited data from human trials exist, this unique method of enhancing the body's own cells to fight cancer offers hope. ^{1 2 3 4 6}

Who Is on the Research Team?

Instil Study Director

Principal Investigator

Instil Bio, Inc.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors like ovarian, lung, or kidney cancer that got worse after standard treatment can join. They must be fit for surgery to remove tumor tissue and have good organ function. Specific criteria apply depending on the type of cancer and previous treatments received.

Inclusion Criteria

I am medically fit for surgery to remove my tumor.

My NSCLC worsened after platinum chemotherapy and CPI, and I've had targeted therapy if I have specific mutations.

My lung cancer is either squamous-cell carcinoma or adenocarcinoma.

Exclusion Criteria

I have had TIL or CAR T-cell therapy before.

I have brain metastases that are either causing symptoms or have not been treated.

I have not had another cancer in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Various doses of ITIL-306 are tested in participants with EOC, NSCLC, and RCC

Expansion

Participants are grouped into cohorts based on cancer type to receive ITIL-306

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• ITIL-306

Trial Overview The trial is testing ITIL-306, a cell therapy made from patients' own immune cells designed to target tumors expressing FOLR1. It's in early stages (phase 1a/1b) to see if it's safe and works as intended.

How Is the Trial Designed?

Group I: Phase 1b: Expansion Experimental Treatment 1 Intervention

Cohort 1: Participants with epithelial ovarian cancer (EOC) Cohort 2: Participants with non-small cell lung cancer (NSCLC) Cohort 3: Participants with renal cell carcinoma (RCC)

Group II: Phase 1a: Dose Escalation Experimental Treatment 1 Intervention

Various doses will be tested in participants with EOC, NSCLC and RCC.

Who Is Running the Clinical Trial?

Instil Bio

Lead Sponsor

Trials

3

Recruited

80+

Citations

1. researchgate.net researchgate.net/publication/365212765_776_ITIL-306-201_A_multicenter_first-in-human_phase_1a1b_study_of_ITIL-306_an_engineered_autologous_tumor-infiltrating_lymphocyte_TIL_cell_therapy_product_in_adults_with_advanced_solid_tumor

776 ITIL-306–201: A multicenter, first-in-human phase 1a/1b ... ⁶ ITIL-306 is an engineered autologous TIL cell therapy that supplements native TCR-specific antigen recognition with synthetic costimulation upon engagement ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05397093

NCT05397093 | ITIL-306 in Advanced Solid Tumors ITIL-306-201 is a phase 1a/1b, multicenter, clinical trial evaluating the safety and feasibility of ITIL-306 in adult participants with advanced solid ...

3. jitc.bmj.com jitc.bmj.com/content/jitc/10/Suppl_2/A807.full.pdf

A multicenter, first-in-human phase 1a/1b study of ITIL-306, ... ITIL-306-201 is a multi- center, single-arm, phase 1a/1b dose escalation and expansion study evaluating the safety and feasibility of ITIL-306 in adult patients ...

4. ir.instilbio.com ir.instilbio.com/news-releases/news-release-details/instil-bio-announces-first-patient-dosed-itil-306-our-first

Instil Bio Announces First Patient Dosed with ITIL-306, our ... Instil's first-in-human Phase 1 study of ITIL-306 is an open-label, multicenter study in patients with non-small cell lung cancer, ovarian ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05397093

ITIL-306 in Advanced Solid Tumors ITIL-306 is in a Phase 1 dose escalation trial in non-small cell lung cancer ('NSCLC'), ovarian cancer, and renal cell carcinoma, with the first patient dosed ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800062815

ITIL 306 - AdisInsight - Springer ITIL 306 is an autologous genetically modified cell therapy made from tumour infiltrating lymphocytes (TILs) that express costimulatory ...