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AvailableNCT06872489

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

Status
Available
Phase
—
Study type
Expanded Access
Enrollment
—
Sponsor
Second Life Therapeutics · Industry
Sex
All
Age
2 Years
Healthy volunteers
—

Summary

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALSL-28.Allogeneic, non-HLA matched, Leucocyte-Tells-based therapy

Timeline

First posted
2025-03-12
Last updated
2025-07-23

Source: ClinicalTrials.gov record NCT06872489. Inclusion in this directory is not an endorsement.