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Soft Tissue SarcomaPhase 1NCT06566092

Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants

A Phase 1 study testing LN-145/LN-144 in people with Soft Tissue Sarcoma and Primary Central Nervous System Carcinoma, run by Iovance Biotherapeutics, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options… Read more about this study

Who is it for?
Ages 6 months to 21 years
What is being tested?
LN-145/LN-144
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
5 sitesUnited States
Study dates
28 Mar 2024to 19 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent.
  • Histologically or cytologically confirmed recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has failed all available curative therapy.
  • Acceptable performance status and an estimated life expectancy of > 6 months.
  • At least one resectable lesion (solitary or aggregate lesions) for TIL generation.
  • Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment.
  • Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection.
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  • All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction.
  • Agreement to abide by the protocol indicated contraception use, including refraining from donating sperm or eggs (ova, oocytes), as appropriate for the age and sexual activity of pediatric, adolescent, and young adult participants and as required by local regulations.
  • Signed informed consent and assent when applicable.
  • Written authorization for use and disclosure of protected health information.
  • Ability to adhere to the study visit schedule and other protocol requirements.
  • Acceptable hematologic parameters.
  • Adequate organ function.
  • Modified Ross criteria class 1 and an LVFS > 25% or an LVEF ≥ 50%.
  • Adequate pulmonary function.
  • Participant and/or the legal guardian who provided consent is willing for the participant to receive optimal supportive care.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up and accompany the participant to the study site on each assessment day according to the SoA.

Who cannot join

  • Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis.
  • Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation.
  • Participants are not eligible if they experience uncontrolled seizures.
  • Participants with history of intracranial hemorrhage/spinal cord hemorrhage.
  • Participant has active uveitis that requires active treatment.
  • Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent.
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  • Participant has any form of primary or acquired immunodeficiency.
  • History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease.
  • History of hypersensitivity reaction to any components of the study intervention.
  • Any other condition that in the investigator's judgment would significantly increase the risks of participation.
  • Any complication or delayed healing from an excisional procedure that in the investigator's opinion would increase the risks of participation.
  • Another primary malignancy within the previous 3 years.
  • History of allogeneic cell or organ transplant.
  • Requiring systemic steroid therapy higher than the physiologic replacement dose.
  • Received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.
  • Any active viral, bacterial, or fungal infection requiring ongoing systemic treatment.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory Solid Tumors

This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist.

Study details include:

  • The study will last up to 2 years after the TIL infusion (Day 0) for each person.
  • The treatment will last up to 10 days for each person.
  • Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.
Being tested
LN-145/LN-144
Keywords
Tumor Infiltrating Lymphocytes, TIL, Pediatric, Soft Tissue Sarcoma, Primary Nervous System Carcinoma, PCNS, Rhabdomyosarcoma, RMS, Ewing Sarcoma, EWS
Medical subject headings
Sarcoma, Melanoma, Rhabdomyosarcoma, Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LN-145/LN-144Biological

    A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.

Study groups in NCT06566092
Study groupRoleWhat they receive
Rhabdomyosarcoma (RMS)ExperimentalNot described
Receives: Biological: LN-145/LN-144
Ewing Sarcoma (EWS)ExperimentalNot described
Receives: Biological: LN-145/LN-144
Primary Central Nervous System TumorExperimentalNot described
Receives: Biological: LN-145/LN-144
MelanomaExperimentalNot described
Receives: Biological: LN-145/LN-144

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of Treatment-Emergent Adverse Events

    To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE.

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Objective Response Rate

    To evaluate the proportion of participants who have confirmed complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.

    Measured: Up to 24 months

  2. Duration of Response

    To measure the time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.

    Measured: Up to 24 months

  3. Disease Control Rate

    To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RECIST v1.1 or RAPNO.

    Measured: Up to 24 months

  4. Progression-Free Survival

    To evaluate the time from the date of the TIL infusion until disease progression per RECIST v1.1 or RAPNO.

    Measured: Up to 24 months

  5. Overall Survival

    To measure the time from the date of TIL infusion to death due to any cause.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start28 Mar 2024
  3. Primary completion19 Jun 2026
  4. Study completion19 Jun 2026

Why it stopped: After reviewing the available safety and efficacy data to date, Iovance has made the decision to conclude all remaining participant visits.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are assigned one of three arms depending on their tumor type.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06566092
Sponsor's protocol ID
IOV-PED-101
Status last verified
Oct 2026
First submitted
17 Jul 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LN-145/LN-144 in people with Soft Tissue Sarcoma and Primary Central Nervous System Carcinoma, run by Iovance Biotherapeutics, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: After reviewing the available safety and efficacy data to date, Iovance has made the decision to conclude all remaining participant visits.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of Treatment-Emergent Adverse Events (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06566092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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