TIL for Cancer

Recruiting at 5 trial locations

Overseen By Iovance Biotherapeutics Study Team

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Iovance Biotherapeutics, Inc.

Must not be taking: Systemic steroids

Disqualifiers: Brain metastases, Seizures, Immunodeficiency, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 10 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TIL, which stands for tumor-infiltrating lymphocytes, to determine its safety and effectiveness in fighting cancer. It targets children, teens, and young adults whose solid tumors, such as Ewing Sarcoma or Melanoma, have returned or resisted other treatments. Participants must have a solid tumor that no longer responds to treatment and at least one tumor that doctors can remove to generate the TIL treatment. The specific TIL treatment under investigation is known as LN-145/LN-144 (also called lifileucel or Amtagvi). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the TIL for Cancer trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy higher than the physiologic replacement dose, you may not be eligible to participate.

Is there any evidence suggesting that the TIL regimen is likely to be safe for humans?

Research has shown that LN-145/LN-144, also known as lifileucel, has been tested for safety in various cancer types. A 5-year study found that lifileucel offers long-term benefits without introducing new safety issues. This treatment uses a patient's own immune cells to help fight cancer.

The treatment plan typically includes other drugs like cyclophosphamide, fludarabine, and IL-2, which can cause side effects. However, no new safety risks have been identified specifically for lifileucel, and patients generally tolerated the treatment well.

Although this study is in an early phase, the treatment has shown promise in other conditions, indicating it is reasonably safe. Participants should discuss potential risks and benefits with their doctors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about LN-145 and LN-144 because these treatments use tumor-infiltrating lymphocytes (TILs), a type of immunotherapy. Unlike traditional treatments like chemotherapy and radiation, which target cancer cells directly, TIL therapy boosts the body's own immune system to fight cancer. This method involves extracting the patient's immune cells, multiplying them in a lab, and reintroducing them to the body to enhance the attack on cancer cells. This personalized approach is promising, especially for hard-to-treat cancers like Ewing Sarcoma, Rhabdomyosarcoma, primary central nervous system tumors, and melanoma, because it harnesses the body’s natural defenses with potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that tumor-infiltrating lymphocyte (TIL) therapy, such as LN-145 and LN-144, holds promise for treating various cancers. In this trial, participants with melanoma will receive lifileucel (a type of TIL therapy), which studies have found can help patients live longer, with nearly 20% surviving for 5 years. Other participants will be treated for Ewing Sarcoma, Rhabdomyosarcoma, and primary central nervous system tumors, where TIL therapy has been observed to shrink tumors in many patients. This treatment uses the patient’s own immune cells to fight cancer and has demonstrated lasting effects in patients with different types of tumors. Overall, early research suggests that TIL therapy could be a good option for cancers that haven't responded to other treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

Iovance Biotherapeutics Study Team

Principal Investigator

Iovance Biotherapeutics

Are You a Good Fit for This Trial?

This trial is for young individuals with certain types of cancer (like Ewing Sarcoma, various sarcomas, brain cancer, and melanoma) that have come back or aren't responding to treatment. It's specifically for those without effective standard treatments available.

Inclusion Criteria

Signed informed consent and assent when applicable

Acceptable hematologic parameters

I am 21 or younger and weigh at least 8 kg.

Exclusion Criteria

Any other condition that in the investigator's judgment would significantly increase the risks of participation

I am on a high dose of steroids, more than the usual replacement dose.

I have brain metastases or carcinomatous meningitis that hasn't been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TIL regimen for up to 10 days

10 days

Daily visits during treatment

Initial Follow-up

Participants are monitored every 2 weeks until Day 42 for safety and effectiveness

6 weeks

Every 2 weeks

Extended Follow-up

Participants are monitored every 6 weeks until Month 6, then every 3 months until Year 2

24 months

Every 6 weeks until Month 6, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• LN-145/LN-144

Trial Overview The study tests the safety and effectiveness of a TIL regimen using LN-145/LN-144 in fighting cancer. Participants will undergo up to 10 days of treatment and be monitored over two years with regular study visits.

How Is the Trial Designed?

Group I: Rhabdomyosarcoma (RMS) Experimental Treatment 1 Intervention

Group II: Primary Central Nervous System Tumor Experimental Treatment 1 Intervention

Group III: Melanoma Experimental Treatment 1 Intervention

Group IV: Ewing Sarcoma (EWS) Experimental Treatment 1 Intervention

LN-145/LN-144 is already approved in United States for the following indications:

Approved in United States as lifileucel (Amtagvi) for:

• Advanced melanoma

Who Is Running the Clinical Trial?

Iovance Biotherapeutics, Inc.

Lead Sponsor

Trials

26

Recruited

1,800+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0147027225000790

Current perspectives on Lifileucel tumor-infiltrating ... The article explores various mechanisms of TIL treatment, analyzes the clinical data supporting the effectiveness of Lifileucel, and assesses its possible ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40454684/

Long-term Efficacy and Safety of Lifileucel Tumor ... This 5-year analysis demonstrated long-term benefit and meaningful OS with one-time lifileucel therapy, with no additional long-term safety concerns.

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432234

Immunotherapy in Sarcoma: Current Data and Promising ... Evidence shows that combining ICIs with chemotherapy has increased efficacy in STS. With anthracycline chemotherapy as the backbone of treatment ...

4. fda.gov fda.gov/media/176893/download

AMTAGVI The major risks of AMTAGVI include prolonged cytopenia, severe infection, internal organ hemorrhage, and cardiopulmonary and renal impairment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05607095

NCT05607095 | A Study of LN-144 or LN-145 in People ... This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma. Official Title. A Pilot Trial of Autologous Tumor ...