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NCT05029336
Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases
Phase 2 trial testing Depletion of CD3/CD19 in an autologous stem cell transplant in Systemic Lupus Erythematosus in 20 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Stephan Grupp MD PhD |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 March 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 May 2031 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Depletion of CD3/CD19 in an autologous stem cell transplant — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
- Systemic Sclerosis — all drugs for Systemic Sclerosis →
Sponsor
Stephan Grupp MD PhD — full company profile →
Who can join
Adults 8 to 25, any sex, with Systemic Lupus Erythematosus or Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Two-year progression free survival
Time frame: 2 years
Survival without evidence of relapse or disease progression
Sponsor's own description
A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy has been used in adults across a myriad of indications with evidence for efficacy. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current cell therapies for systemic lupus erythematosus.
Dao LTM, Vu TT, Nguyen QT, Hoang VT, et al · · 2024 · cited 16× · PMID 38920310 · DOI 10.1093/stcltm/szae044 -
Advances in hematopoietic stem cell transplantation for autoimmune diseases.
Xu Y, Wang X, Hu Z, Huang R, et al · · 2024 · cited 4× · PMID 39492896 · DOI 10.1016/j.heliyon.2024.e39302 -
Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7 -
Beyond conventional treatment: Novel cell therapies for systemic lupus erythematosus.
Zarei-Behjani Z, Hosseinpouri A, Fotoohi M, Shafiee A, et al · · 2025 · PMID 40978494 · DOI 10.1016/j.jtauto.2025.100308
Verify or expand the search:
- PubMed search for NCT05029336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
- NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
- NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting
Other Stephan Grupp MD PhD trials
Trials by the same sponsor.
- NCT07464951 — CART123 Cells With or Without Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · not yet recruiting
- NCT07007117 — PHOX2B PC-CAR T Cells for Relapsed Neuroblastoma · Phase 1 · recruiting
- NCT06934382 — Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma · Phase 1 · recruiting
- NCT05650749 — GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma · Phase 1 · recruiting
- NCT05674175 — Co-administration of CART22-65s and huCART19 for B-ALL · Phase 1, PHASE2 · recruiting
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 NCT05029336 (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 Stephan Grupp MD PhD
- Last refreshed: 9 October 2025
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/NCT05029336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing