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CAR T-cell Therapy

TIL for Cancer

Phase 1
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent
Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment
Must not have
Requiring systemic steroid therapy higher than the physiologic replacement dose
Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test a new treatment called TIL to see if it is safe and effective in fighting cancer in children, teenagers, and young adults with solid tumors that have not responded to other treatments.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, TIL therapy can generally cause flu-like symptoms, fatigue, rash, and may affect blood counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 or younger and weigh at least 8 kg.
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I still have at least one tumor that can be measured after surgery.
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My heart functions well according to specific health standards.
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My cancer has returned or didn't respond to treatment and no other cure is available.
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I have at least one tumor that can be surgically removed for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on a high dose of steroids, more than the usual replacement dose.
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I have brain metastases or carcinomatous meningitis that hasn't been treated.
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I do not have seizures that are currently uncontrolled.
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I have had bleeding in my brain or spinal cord.
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I am currently receiving treatment for active uveitis.
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I have not had a live vaccine within the last 28 days.
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I am currently being treated for an ongoing infection.
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I have a long-term lung condition like COPD, asthma, or similar.
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I have not had another cancer in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence rate of Treatment-Emergent Adverse Events
Secondary study objectives
Disease Control Rate
Duration of Response
Objective Response Rate
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Rhabdomyosarcoma (RMS)Experimental Treatment1 Intervention
Group II: Primary Central Nervous System TumorExperimental Treatment1 Intervention
Group III: MelanomaExperimental Treatment1 Intervention
Group IV: Ewing Sarcoma (EWS)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
1,832 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
4 Previous Clinical Trials
953 Total Patients Enrolled
~27 spots leftby Jul 2026
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