A Phase 1 Study of LN-145 and LN-144 in Children, Adolescents, and Young Adults With Solid Tumors

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Full Title

A Phase 1, multicenter, open-label, 2-stage, single-arm study to evaluate the safety and tolerability of an autologous tumor-infiltrating lymphocytes (TIL) regimen and preliminary antitumor activity of TIL in pediatric, adolescent, and young adult participants with relapsed or refractory solid tumors

Purpose

This study is assessing a new form of immunotherapy for young people with solid tumors. The people in this study have melanoma, soft tissue sarcoma, or brain or spinal cord cancer. In addition, their cancers keep growing or came back after treatment.

The study therapies are called LN-145 and LN-144. They activate white blood cells to attack tumors. LN-145 and LN-144 are autologous tumor infiltrating lymphocyte (TIL) therapies. They are made from your own white blood cells called lymphocytes (or T cells).

If you join this study, we will collect some T cells from your tumor and send them to a laboratory. There they will be used to make the study therapy, which is designed to attack your cancer cells.

LN-144 is the name of the TIL made from melanoma tumors. LN-145 is the TIL is made from soft tissue sarcomas and brain and spinal cord tumors. People in this study with melanoma will receive LN-144. Those with soft tissue sarcoma or brain or spinal cord cancer will receive LN-145.

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have melanoma, soft tissue sarcoma, or brain or spinal cord cancer that came back or keeps growing after treatment.
  • Have recovered from the serious side effects of prior cancer therapies before getting the study treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 21 or younger.

Contact

For more information and to see if you or your child can join this study, please call 833-MSK-KIDS.

Protocol

24-170

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT06566092