Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Gene-Hacked immune cells take on tough cancers

NCT ID NCT05361174

Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment called IOV-4001 for people with advanced melanoma or non-small-cell lung cancer. The treatment uses a patient's own tumor-fighting immune cells, which are collected, genetically modified to remove a 'brake' called PD-1, and then infused back after chemotherapy. The goal is to see if this personalized cell therapy is safe and can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IOV-4001 (a personalized cell therapy made from a patient's own tumor-fighting immune cells, genetically modified to remove the PD-1 checkpoint)
What this could lead to
If successful, this could offer a new treatment option for people with advanced melanoma or lung cancer who have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 53 participants, so results may not apply to everyone. The treatment involves intensive chemotherapy and carries risks of serious side effects.
Why investors are watching

Iovance Biotherapeutics is testing IOV-4001, a cell therapy made from a patient's own tumor-fighting cells that have been edited to remove a protein called PD-1, in people with advanced melanoma or lung cancer. For a small company, this early-stage trial is a key test of whether its next-generation approach can work safely and control disease. A clear signal in either cancer type would show the company has a product beyond its current pipeline.

If it works: If the trial shows IOV-4001 shrinks tumors or slows disease in a meaningful share of patients, Iovance could gain a stronger position in cell therapy for solid tumors. That result might attract partners or support further development toward a larger study.

If it fails: Early-phase trials often fail because the treatment is not effective enough or causes serious side effects. A poor result or a delay in enrollment could set the program back and put pressure on the company's value, since Iovance depends on this candidate's success.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 53 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC. 2. Participants who have received the following previous therapy: 1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations. 2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and: * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody * those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either: * platinum doublet chemotherapy * Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Participants who is assessed as having at least one resectable lesion. 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation. 6. Participants who have adequate organ function. 7. Cardiac function test required. 8. Pulmonary function test may be required. 9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months. 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. Exclusion Criteria: 1. Participants who have melanoma of uveal/ocular origin. 2. Participants who have symptomatic untreated brain metastases. 3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. 4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose. 5. Participants who have any form of primary immunodeficiency. 6. Participants who have another primary malignancy within the previous 3 years. 7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bronchial neoplasm carcinoma lung disorder lung neoplasm melanoma metastatic melanoma neoplasm non-small cell lung carcinoma skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma Stage III non-small cell lung cancer Stage IV non-small cell lung cancer Unresectable melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Medical College of Wisconsin

    WITHDRAWN

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32610, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The Angeles Clinic and Research Institute

    RECRUITING

    Los Angeles, California, 90025, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Weill Medical College of Cornell University

    RECRUITING

    New York, New York, 10022, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.