CLINICAL TRIAL

LN-145-S1 for Oral Squamous Cell Carcinoma

Waitlist Available · 18+ · All Sexes · Newark, DE

This study is evaluating whether adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145/LN-145-S1) followed by IL-2 after a non-myeloablative (NMA) lymphodeplet

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Squamous Cell Carcinoma of Head and Neck · Squamous Cell Carcinoma of the Head and Neck · Carcinoma, Squamous Cell · Carcinoma

Treatment Groups

This trial involves 5 different treatments. LN-145-S1 is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
LN-145
BIOLOGICAL
+
LN-145-S1
BIOLOGICAL
Experimental Group 2
LN-145
BIOLOGICAL
Experimental Group 3
LN-145-S1
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Must be greater than 18 years of age at the time of consent.
Must have recurrent and/or metastatic, squamous cell carcinoma of the head and neck (both HPV-positive and -negative)
Must have at least 1 lesion that is resectable for TIL generation.
Must have measurable disease as defined by RECIST v1.1 following the surgical resection.
Must have received at least 1 and no more than 3 lines of prior systemic immunotherapy and/or chemotherapeutic treatments for HNSCC.
Any prior therapy directed at the malignant tumor must be discontinued at least 28 days prior to lymphodepletion.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 36 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether LN-145-S1 will improve 1 primary outcome and 5 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 24 months.

Disease Control Rate
UP TO 24 MONTHS
To evaluate efficacy parameters such as Disease Control Rate (DCR) using RECIST v1.1 as assessed by the Investigator
Duration of Response
UP TO 24 MONTHS
To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator
Progression-Free Survival
UP TO 24 MONTHS
To evaluate efficacy parameters such as Progression-Free Survival (PFS) using RECIST v1.1 as assessed by the Investigator
Safety Profile as Assessed by Incidence of Adverse Events
UP TO 24 MONTHS
To characterize the safety profile of LN-145/LN-145-S1 in patients with metastatic and/or recurrent HNSCC
Objective Response Rate
UP TO 24 MONTHS
To evaluate the efficacy of LN-145/LN-145-S1 in patients with recurrent and/or metastatic HNSCC based on the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Overall Survival
UP TO 36 MONTHS
To evaluate Overall Survival (OS) in patients with recurrent and/or metastatic HNSCC

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of oral squamous cell carcinoma?

The major risk factor for oral carcinoma was alcohol ingestion (70%), which was mainly explained by heavy and long duration of the consumption of alcohol.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

These data show that standard radiotherapy treatment is most common and that radiotherapy (combined with radiotherapy or surgery) is the most frequent treatment given to patients who have already received surgery. Further, combined radiotherapy and surgery is the most common salvage treatment for patients who have failed surgery. Patients undergoing radiotherapy generally have good clinical outcomes. Oral surgeons typically do not see a large number of patients who need treatment for OSCC, so the majority of patients with cancer of the oral cavity will be treated by an oncology specialist. A clinical trials website may be useful in helping people with OSCC find trials that are appropriate for their condition, treatment, and location. The most important treatments are those with the most evidence of effectiveness for OSCC.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

Most reported risk factors for HPV-associated OSSCC were based on studies on the general population, which could be prone to bias. Also, not all studies evaluated the HPV status of all subjects undergoing surgery. The risk factors of OSSCC in a patient's environment were similar to those found in the general population, but still needed further validation. More studies are needed to determine the exact factors that cause OSSCC.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

These rates are consistent with data reported from other published sources. To the best of our knowledge, this is the first report of age- and sex-standardized OSCC incidence rates to include all races and all socioeconomic groups in the United States. Further investigations will be required to determine incidence patterns of this common neoplasm among Hispanic and Black populations.

Anonymous Patient Answer

How many people get oral squamous cell carcinoma a year in the United States?

Nearly 1 in 3 men will develop some form of cancer in time to death. About 175,000 people in the US will die each year from oral cancer. This represents about 2% of all cancer cases (about 2% of all cancer related deaths) in the US.

Anonymous Patient Answer

Can oral squamous cell carcinoma be cured?

Although the majority of patients (84%) do show positive tumour stage in their primary site and distant metastasis to the lymph nodes, only 13% (14 of 111 tumours) had a distant metastasis with the disease, and half (54%) showed a recurrent tumor after surgery, with the most frequently involved sites being the lymph nodes and lungs. No statistically significant differences were found between the groups in terms of survival after treatment.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Some signs of oral squamous cell carcinoma include a sore throat, a dry mouth, trouble swallowing and pain on the tongue. Oral squamous cell carcinoma can be identified through visual examination. Tissue biopsy is an effective way to detect oral squamous cell carcinoma. It can also enable the early diagnosis of oral squamous cell carcinoma. If oral squamous cell carcinoma is not detected at diagnosis, it often recurs in the following months to years.

Anonymous Patient Answer

What is the latest research for oral squamous cell carcinoma?

With the research in the past 10years, [therapy options for OSCC patients] are improving. This improvement is a result of the new drugs and treatments on the market. Recent studies show that a higher quality of life is achievable in patients with advanced SCC when the physicians use [therapy options for OSCC patients]. There is an increased motivation to help patients that are not willing to have surgery or radiation, and hence a better satisfaction for them.

Anonymous Patient Answer

How does ln-145-s1 work?

[A 2014 review has found that ln-145-s1 may have efficacy in cutaneous T-cell lymphoma as a single agent or in combination with rituximab for cutaneous T-cell lymphoma] shows that the current understanding of the mechanism of action for ln-145-s1 in SCC appears to be valid. The findings in the reviews show that ln-145-s1 decreases cell viability by induction of apoptosis and necrosis, by modulation of MAPK signaling, and by interference with DNA synthesis. Further studies are needed to elucidate the mechanisms through which ln-145-s1 induces apoptosis, necrosis, and cell cycle arrest in SCC.

Anonymous Patient Answer

What are the latest developments in ln-145-s1 for therapeutic use?

ln-145-s1 has a strong antitumor profile in murine models for oral squamous cell cancer (OSCC) and warrants further investigation as a therapeutic agent for this indication. Further studies are warranted to determine the optimal dose and schedule of ln-145-s1, and to explore the role of ln-145-s1 in combination with known conventional therapies. In contrast to other anticancer agents, ln-145-s1 is active in the presence of tumor cell hypoxic fraction and warrants evaluation of this property.

Anonymous Patient Answer

What does ln-145-s1 usually treat?

The above cases had very low cancer recurrence rates. The most common sites of recurrence were cervical and non-squamous cell carcinoma of the head and neck. Ln-145-s1 effectively treats squamous cell carcinoma of the head and neck and non-squamous cell carcinoma of the oral cavity. The most common sites for recurrence include both types of oral cavity cancer. Ln-145-s1 is used on an individual basis.

Anonymous Patient Answer

Does ln-145-s1 improve quality of life for those with oral squamous cell carcinoma?

We provide evidence through the use of a novel health care system that patients with oral SCC have a substantial decrement in QOL in the months after surgery, particularly in terms of pain and global depression. However, even so, the use of Ln-145S1 did not provide a statistically significant difference in terms of QOL as compared with placebo. Further studies with larger case series are needed to confirm these results.

Anonymous Patient Answer
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