SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP for Neuroblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neuroblastoma
SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will test the safety of a new combination vaccine for patients with high risk neuroblastoma, as well as its ability to elicit an immune response and shrink tumors.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Evaluate the immune response to these immunizations.
Evaluate the safety of repeated immunization with gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-Lptn cells co-administered with the unmodified SKNLP neuroblastoma cell line.

Trial Safety

Side Effects for

Abl Cells IA + MTD IL-2
86%Platelet count decreased
86%Lymphocyte count decreased
71%Leukocyte count decreased
71%Hemoglobin decreased
71%Neutrophil count decreased
57%Serum calcium decreased
43%Fatigue
43%Serum albumin decreased
29%Myalgia
29%Serum sodium decreased
29%Somnolence/depressed level of consciousness
29%Fever
29%Activated partial thromboplastin time prolonged
29%Febrile Neutropenia
29%Serum phosphate decreased
29%Nausea
29%Serum potassium increased
29%Creatinine increased
29%Bilirubin increased
29%Rash desquamating
29%Chills
14%Constipation
14%Weight loss
14%Aspartate aminotransferase increased
14%Catheter-related infection
14%Alkaline phosphatase increased
14%Rectal bleeding/hematochezia
14%Serum magnesium increased
14%Dyspnea
14%Thrombotic microangiopathy
14%Hypotension
14%Renal failure
14%Hypoxia
14%Anxiety
14%INR increased
14%Blood uric acid increased
14%Headache
14%Serum calcium increased
14%Injection site reaction
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT00001832) in the Abl Cells IA + MTD IL-2 ARM group. Side effects include: Platelet count decreased with 86%, Lymphocyte count decreased with 86%, Leukocyte count decreased with 71%, Hemoglobin decreased with 71%, Neutrophil count decreased with 71%.

Trial Design

2 Treatment Groups

Dose Level 1
1 of 2
Dose Level 2
1 of 2

Experimental Treatment

7 Total Participants · 2 Treatment Groups

Primary Treatment: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP · No Placebo Group · Phase 1 & 2

Dose Level 1
Biological
Experimental Group · 1 Intervention: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP · Intervention Types: Biological
Dose Level 2
Biological
Experimental Group · 1 Intervention: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
915 Previous Clinical Trials
5,982,832 Total Patients Enrolled
13 Trials studying Neuroblastoma
298 Patients Enrolled for Neuroblastoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
108 Previous Clinical Trials
2,796 Total Patients Enrolled
11 Trials studying Neuroblastoma
256 Patients Enrolled for Neuroblastoma
Andras A. Heczey, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
22 Total Patients Enrolled
2 Trials studying Neuroblastoma
22 Patients Enrolled for Neuroblastoma

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must be willing to use one of the more effective birth control methods during the study and for 6 months after the study is concluded

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.