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Trial Title:
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
NCT ID:
NCT06566092
Condition:
Soft Tissue Sarcoma
Primary Central Nervous System Carcinoma
Melanoma
Rhabdomyosarcoma
Ewing Sarcoma
Conditions: Official terms:
Sarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Conditions: Keywords:
Tumor Infiltrating Lymphocytes
TIL
Pediatric
Soft Tissue Sarcoma
Primary Nervous System Carcinoma
PCNS
Rhabdomyosarcoma
RMS
Ewing Sarcoma
EWS
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants are assigned one of three arms depending on their tumor type.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LN-145/LN-144
Description:
A tumor sample is resected from each patient and cultured ex vivo to expand the
population of tumor infiltrating lymphocytes.
Arm group label:
Ewing Sarcoma (EWS)
Arm group label:
Melanoma
Arm group label:
Primary Central Nervous System Tumor
Arm group label:
Rhabdomyosarcoma (RMS)
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and
assent.
2. 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.
3. Acceptable performance status and an estimated life expectancy of > 6 months.
4. At least one resectable lesion (solitary or aggregate lesions) for TIL generation.
5. Following tumor resection for TIL generation, the participant will have at least one
remaining measurable lesion for response assessment.
6. Preplanned surgical procedure(s) will take place at least 14 days (for major
operative procedures) prior to the tumor resection.
7. All prior anticancer treatment-related AEs should be recovered, exceptions are
peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine
dysfunction.
8. 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.
9. Signed informed consent and assent when applicable.
10. Written authorization for use and disclosure of protected health information.
11. Ability to adhere to the study visit schedule and other protocol requirements.
12. Acceptable hematologic parameters.
13. Adequate organ function.
14. Modified Ross criteria class 1 and an LVFS > 25% or an LVEF ≥ 50%.
15. Adequate pulmonary function.
16. Participant and/or the legal guardian who provided consent is willing for the
participant to receive optimal supportive care.
17. 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.
Exclusion Criteria:
1. Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or
carcinomatous meningitis.
2. Participant has an active or uncontrolled intercurrent illness(es) that would pose
increased risks for study participation.
3. Participants are not eligible if they experience uncontrolled seizures.
4. Participants with history of intracranial hemorrhage/spinal cord hemorrhage.
5. Participant has active uveitis that requires active treatment.
6. Participant has significant psychiatric disease or substance abuse in the
investigator's opinion that would prevent adequate informed consent.
7. Participant has any form of primary or acquired immunodeficiency.
8. History of clinically significant chronic obstructive pulmonary disease, asthma,
interstitial lung disease, or other chronic lung disease.
9. History of hypersensitivity reaction to any components of the study intervention.
10. Any other condition that in the investigator's judgment would significantly increase
the risks of participation.
11. Any complication or delayed healing from an excisional procedure that in the
investigator's opinion would increase the risks of participation.
12. Another primary malignancy within the previous 3 years.
13. History of allogeneic cell or organ transplant.
14. Requiring systemic steroid therapy higher than the physiologic replacement dose.
15. Received or will receive a live or attenuated vaccination within 28 days prior to
the start of the NMA-LD.
16. Any active viral, bacterial, or fungal infection requiring ongoing systemic
treatment.
Gender:
All
Minimum age:
6 Months
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rutgers Cancer Institute
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Start date:
March 28, 2024
Completion date:
July 2028
Lead sponsor:
Agency:
Iovance Biotherapeutics, Inc.
Agency class:
Industry
Source:
Iovance Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06566092
