Expanded Access Program for SL-28 in Treating Advanced Solid Tumors

Sponsor: Second Life Therapeutics

Expanded Access
Sponsor score: 0

ClinicalTrials ID:NCT06872489

Provider View

This program provides access to the experimental drug SL-28 for patients with advanced solid tumors who have not responded to standard treatments. SL-28 is a cell-based therapy using special white blood cells from healthy donors, and it is given through an IV over several days.

Patient Parameters

Program Overview

This Expanded Access Program allows patients with advanced solid tumors to receive the experimental drug SL-28 before it is officially approved. The drug is designed to target and fight different types of tumors. SL-28 is made from white blood cells taken from healthy donors, which are then processed and stored until needed. Patients will receive SL-28 through an IV on specific days, and their response to the treatment will determine if additional doses are needed. The program is open to adults and older adults aged 18 to 65 and older who meet certain criteria.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumor.
  • Have at least one tumor that can be measured or evaluated.
  • For patients with relapsed or hard-to-treat neuroblastoma, a performance status score of 50% or higher is required.
  • Have a performance status score of 0 to 3, indicating varying levels of activity.
  • Expected to live for more than 12 weeks.
  • Aged 2 to 65 and older, with no gender restrictions.
  • Must provide informed consent and agree to follow study procedures.
  • Have adequate bone marrow and organ function.
  • Have not responded to first-line treatments or have recurring or hard-to-treat disease.
  • Women of childbearing potential must agree to use effective contraception or abstain from sex during the study and for at least one week after the last dose.
  • Must have a negative pregnancy test before starting treatment and not be breastfeeding.
  • Male patients with partners of reproductive age must agree to use contraception or abstain from sex during the study and for at least one week after the last dose.
  • Must wait at least 42 days after completing any immunotherapy and 60 days after radiation therapy before starting SL-28.
  • Must stop cytokine therapy at least 7 days before starting SL-28.

Exclusion Criteria

  • Have untreated or active brain tumors or metastases.
  • Have primary or secondary immune system deficiencies.
  • Have major organ diseases that would make treatment unsafe.
  • Have had blood clots or strokes in the past 12 months.
  • Have known allergies to any study drugs or ingredients.
  • Are on hemodialysis.
  • Are pregnant or breastfeeding, or are not willing to use contraception if fertile.
  • Have untreated positive blood cultures or ongoing infections.

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