Neuroblastoma in ChildrenNCT06872489
Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors
A study testing SL-28. in people with Neuroblastoma in Children and Neuroblastoma, Recurrent, Refractory, run by Second Life Therapeutics.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Neuroblastoma in Children, Neuroblastoma, Recurrent, Refractory, Advanced Cancer
- What is being tested?
- SL-28.
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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;
- The expected survival time is more than 12 weeks;
- 2 to 65+ old, gender is not limited;
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- The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
- Be able to comply with trial and follow-up procedures;
- Adequate bone marrow and organ function;
- Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);
- Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.
- The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
- For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.
- Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;
- Radiation therapy: 60 days should have elapsed in the case of completing radiation.
- Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.
Who cannot join
- 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;
- Known allergy to any of the agents or their ingredients used in this study;
- Patients who are on hemodialysis;
- Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;
- Patients with untreated positive blood cultures or progressive infections.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Neuroblastoma in Children, Neuroblastoma, Recurrent, Refractory, Advanced Cancer, Advanced Malignant Neoplasm, Prostate Cancer Patients With Bone Metastasis, Lung Cancer Non-Small Cell Cancer (NSCLC)
- Being tested
- SL-28.
- Medical subject headings
- Neuroblastoma, Recurrence, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-28.Biological
Allogeneic, non-HLA matched, Leucocyte-Tells-based therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroblastoma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Second Life Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872489
- Sponsor's protocol ID
- SL28-NBL-G4407
- Status last verified
- Jul 2025
- First submitted
- 3 Mar 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06872489
- Acronym / sponsor ID
- SL28-NBL-G4407
- Conditions
- Neuroblastoma in Children, Neuroblastoma, Recurrent, Refractory, Advanced Cancer, Advanced Malignant Neoplasm, Prostate Cancer Patients With Bone Metastasis, Lung Cancer Non-Small Cell Cancer (NSCLC)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Second Life TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
- The expected survival time is more than 12 weeks;
Key exclusion criteria (8 listed)
- 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;
- Known allergy to any of the agents or their ingredients used in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-28.Allogeneic, non-HLA matched, Leucocyte-Tells-based therapy | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing SL-28. in people with Neuroblastoma in Children and Neuroblastoma, Recurrent, Refractory, run by Second Life Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Tetz, MD, PhD (+1-646-617-3088, g.tetz@sltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.