US Clinical Trial
ISH4/HiSCR V1
HCP Factsheet V1
Participant Emergency Contact Card V1
Participant Thank You Card V1
Subject Eligibility Forms (combined PDF) V1
Subject Eligibility Forms (combined PDF) V2
Subject Eligibility Forms (combined PDF) V3
Subject Eligibility Forms (combined PDF) V4
Pre-Screening Checklist V1
Schedule of Assessments (Baseline-Safety Follow-up) V2
Schedule of Assessments (Screening - Pretreatment) V2
Pre-Screening Slot Request Form v14Mar2024
Enhanced Brochure V1
Participant Handbook V1
Participant Journey V1
Trial Participant Companion Reminder V1
Patient Intro to CAR-T Regulatory Cell Infusion White Paper
Week 1 V1
Week 2 V1
Week 3 V1
Week 4 V1
Weeks 5-6 V1
Weeks 7-8 V1
Weeks 9-10 V1
Weeks 11-12 V1
Weeks 13-18 V1
Weeks 19-24 V1
Weeks 25-36 V1
Weeks 37-48 V1
1. Table of Contents
2. Study Team List
3. Study Supplies Request Template
4. ClinTrak Access Request Management Site Instructions
5. Clinical Study Protocol
5a. Clinical Study Protocol V3
5b. Protocol Clarification Letter
6. Investigator's Brochure
7. IP Manual
8. IP Preparation and Administration Form
9. IP Disposal and Destruction Form
10. Site Signature Responsibility Log
11. Site Personnel Training Log
12. Safety Monitoring Committee Charter
13. Exposure in Utero Form
14. Backup SAE Form
15. Site Visit Log Form
16. Lab Manual
17. Quick Reference Chart
18. Laboratory Re-Supply Form
19. eCRF Completion Guideline
20. Sonoma Apheresis Collection Protocol
21. Study Operations Manual
22. Skin Biopsy Manual
1. Table of Contents
2. Study Team List
3. Study Supplies Request Template
4. ClinTrak Access Request Management Site Instructions
5. Clinical Study Protocol
5a. Clinical Study Protocol V3
5b. Protocol Clarification Letter
6. Investigator's Brochure
7. IP Manual
8. IP Preparation and Administration Form
9. IP Disposal and Destruction Form
10. Site Signature Responsibility Log
11. Site Personnel Training Log
12. Safety Monitoring Committee Charter
13. Exposure in Utero Form
14. Backup SAE Form
15. Site Visit Log Form
16. Lab Manual
17. Quick Reference Chart
18. Laboratory Re-Supply Form
19. eCRF Completion Guideline
20. Sonoma Apheresis Collection Protocol
21. Study Operations Manual
22. Skin Biopsy Manual
1. Table of Contents
2. Study Team List
3. Study Supplies Request Template
4. ClinTrak Access Request Management Site Instructions
5. Clinical Study Protocol
5a. Clinical Study Protocol V3
5b. Protocol Clarification Letter
6. Investigator's Brochure
7. IP Manual
8. IP Preparation and Administration Form
9. IP Disposal and Destruction Form
10. Site Signature Responsibility Log
11. Site Personnel Training Log
12. Safety Monitoring Committee Charter
13. Exposure in Utero Form
14. Backup SAE Form
15. Site Visit Log Form
16. Lab Manual
17. Quick Reference Chart
18. Laboratory Re-Supply Form
19. eCRF Completion Guideline
20. Sonoma Apheresis Collection Protocol
21. Study Operations Manual
22. Skin Biopsy Manual