ITIL-306 for Advanced Cancer

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

51 Participants Needed

Trial Summary

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.

What safety data exists for the treatment ITIL-306 in humans?

The treatment involving ifosfamide and paclitaxel has been studied in various cancers, showing some side effects like nausea, vomiting, and blood-related issues such as low white blood cell counts and fever. In some cases, severe side effects like kidney problems and infections were reported, but these were generally manageable with supportive care. ^{1 2 3 4 5}

What is the purpose of this trial?

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 tumors whose disease has progressed after standard therapy. ITIL-306 is a cell therapy derived from a participant's own tumor-infiltrating immune cells (lymphocytes; TILs) and contains a unique molecule designed to increase TIL activity when it encounters folate receptor α (FOLR1) on the tumor.

Research Team

Instil Study Director

Principal Investigator

Instil Bio, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Paclitaxel, ifosfamide and cisplatin with granulocyte colony-stimulating factor or recombinant human interleukin 3 and granulocyte colony-stimulating factor in ovarian cancer: a feasibility study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Paclitaxel plus ifosfamide in advanced ovarian cancer: results of a phase I study. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

[Ifosfamide and Paclitaxel for Recurrent or Metastatic Uterine Carcinosarcoma]. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Combined chemotherapy of weekly paclitaxel and ifosfamide in the treatment of 23 patients with advanced non-small cell lung cancer]. [2011]

5. Germany pubmed.ncbi.nlm.nih.gov

Cisplatin/etoposide/ifosfamide stepwise dose escalation with concomitant granulocyte/macrophage-colony-stimulating factor for patients with far-advanced testicular carcinoma. [2019]