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.
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
- Conditions the study is for
- Soft Tissue Sarcoma, Primary Central Nervous System Carcinoma, Melanoma
- 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
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
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.
- Conditions
- Soft Tissue Sarcoma, Primary Central Nervous System Carcinoma, Melanoma, Rhabdomyosarcoma, Ewing Sarcoma
- 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 group | Role | What they receive |
|---|---|---|
| Rhabdomyosarcoma (RMS) | Experimental | Not described Receives: Biological: LN-145/LN-144 |
| Ewing Sarcoma (EWS) | Experimental | Not described Receives: Biological: LN-145/LN-144 |
| Primary Central Nervous System Tumor | Experimental | Not described Receives: Biological: LN-145/LN-144 |
| Melanoma | Experimental | Not described Receives: Biological: LN-145/LN-144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted22 Aug 2024
- Study start28 Mar 2024
- Primary completion19 Jun 2026
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iovance Biotherapeutics Study Team, Study director, Iovance Biotherapeutics
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