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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor

23 Previous Clinical Trials

1,785 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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