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NCT06287086
Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease
NA trial testing BRL-101 autologous hematopoietic stem and progenitor cells injection in Sickle Cell Disease in 1 participant. Not yet recruiting.
20 August 2025
Quick facts
| Lead sponsor | Bioray Laboratories |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 14 June 2024 |
| Primary completion | 20 August 2025 |
| Estimated completion | 10 June 2026 |
Drugs / interventions tested
- BRL-101 autologous hematopoietic stem and progenitor cells injection — full drug profile →
Conditions studied
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
Sponsor
Bioray Laboratories — full company profile →
Who can join
Adults 3 to 35, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances in therapeutic gene-editing technologies.
Liu D, Cao D, Han R. · · 2025 · cited 17× · PMID 40119516 · DOI 10.1016/j.ymthe.2025.03.026 -
Current and future treatments for sickle cell disease: From hematopoietic stem cell transplantation to in vivo gene therapy.
Ball J, Bradley A, Le A, Tisdale JF, et al · · 2025 · cited 5× · PMID 40083162 · DOI 10.1016/j.ymthe.2025.03.016 -
CRISPR CLIP: comprehensive reviews on interventional studies using precision recombinant technologies: clinical landmarks, implications, and prospects.
Chodnekar SY, Tsetskhladze Z. · · 2024 · cited 1× · PMID 39659430 · DOI 10.1093/oxfimm/iqae013 -
Clinical Trial Landscape of Gene-Edited Autologous Hematopoietic Stem Cells for Hemoglobinopathies and Immunodeficiencies.
O'Hanlon Cohrt K, O'Dea S. · · 2026 · PMID 42074029 · DOI 10.3390/ijms27083384 -
Integrating CRISPR/Cas technology with clinical trials: Principles, progress and challenges.
Yang P, Khoshandam M, Bhia I, Raji S, et al · · 2025 · PMID 41809894 · DOI 10.1016/j.ajps.2025.101068 -
Therapeutic applications of CRISPR-Cas9 gene editing.
Bharti A, Mudge J. · · 2025 · PMID 41476860 · DOI 10.3389/fgeed.2025.1724291 -
Emerging trends in gene and cell therapy: CRISPR in DNA editing and beyond.
Ji R, Chen Q, Zhang Y. · · 2026 · PMID 41418774 · DOI 10.1016/j.xcrm.2025.102459 -
Gene therapy for hemoglobinopathies: Clinical trial results and biology of hematopoietic stem cell and the bone marrow niche.
Aprile A, Lidonnici MR, Ferrari G. · · 2025 · PMID 41253147 · DOI 10.1016/j.xcrm.2025.102419
Verify or expand the search:
- PubMed search for NCT06287086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
- NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
Other Bioray Laboratories trials
Trials by the same sponsor.
- NCT07248176 — Universal CAR-T Cell Therapy for MM · NA · recruiting
- NCT07248163 — Universal CAR-T Cell Therapy for NHL · NA · recruiting
- NCT06298630 — Long-term Follow-up Study of BRL-101 for TDT · not yet recruiting
- NCT06633042 — The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD · Phase 1 · not yet recruiting
- NCT06300723 — Clinical Study of BRL-101 in Severe SCD · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06287086 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bioray Laboratories
- Last refreshed: 3 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06287086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing