Gene Therapy for Metastatic Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

Recruiting Phase 2 Interventional Study
Endocrine Tumors Non-Small Cell Lung Cancer Ovarian Cancer Breast Cancer Gastrointestinal/Genitourinary Cancers Neuroendocrine Tumors Multiple Myeloma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 72
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
285 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for people with certain types of cancer that have not responded to standard treatments. Participants will provide blood to have their white blood cells modified in a lab and then receive treatment in the hospital.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with metastatic cancer.
  • I have cancer that has not responded to standard treatments.
  • I am between 18 and 72 years old.
  • I do not have any major health problems.
  • I am willing to practice birth control for at least 12 months after treatment.
  • I have three or fewer brain metastases that are less than 1 cm and not causing symptoms.
  • I can understand and sign a consent form.
  • I have completed any prior cancer treatments.

You may not be able to join if

  • I am pregnant or nursing.
  • I have a major autoimmune disease.
  • I have any active infections that need treatment.
  • I am taking systemic steroids.
  • I have untreated major bronchial occlusion or bleeding.
  • I have a history of severe immunodeficiency.
  • I have experienced severe organ-related side effects from previous treatments.
  • I currently have opportunistic infections.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells ab…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: * Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, …
Contacts

NCI SB Immunotherapy Recruitment Center

(866) 820-4505

IRC@nih.gov

CONTACT