Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age2+
SponsorSecond Life Therapeutics

About this trial

This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.

Researchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.

SL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.

Eligibility criteria

Qualifiers

Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;

Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);

For patients with relapsed/refractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;

ECOG Performance Status from 0 or 3;

Disqualifiers

Untreated or active primary central nervous system (CNS) tumor or metastasis;

Patients diagnosed of having primary and secondary immunodeficiencies;

Patients with disease of any major organ system that would compromise their ability to withstand therapy.

Arterial/venous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;

Trial design

Treatments tested in this trial

  • SL-28.

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators