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NCT05994157
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1 trial testing CD38-SADA:177Lu-DOTA Complex in Non-hodgkin Lymphoma in 1 participant. Terminated before completion.
15 October 2025
Quick facts
| Lead sponsor | Y-mAbs Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 21 April 2025 |
| Primary completion | 15 October 2025 |
| Estimated completion | 15 October 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- CD38-SADA:177Lu-DOTA Complex — full drug profile →
Conditions studied
- Non-hodgkin Lymphoma — all drugs for Non-hodgkin Lymphoma →
Sponsor
Y-mAbs Therapeutics — full company profile →
Who can join
18 and older, any sex, with Non-hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
<sup>225</sup>Ac α-Pretargeted Radioimmunotherapy of Human Epidermal Growth Factor Receptor 2-Expressing Breast Cancer.
Rinne SS, Burnes Vargas D, Seo S, Veach D, et al · · 2025 · cited 2× · PMID 40473462 · DOI 10.2967/jnumed.125.269601 -
Establishment of <sup>68</sup>Ga-DOTA-Based Pretargeted Radioimmunodiagnosis.
Veach DR, Burnes Vargas D, Islam B, Lee SG, et al · · 2026 · PMID 42151769 · DOI 10.1021/acs.molpharmaceut.5c01766 -
Immunotheranostics in Solid Tumors: Longitudinal Tracking of Human IL13Rα2 CAR-T Cells In Vivo.
Mirzaei HR, Lovibond S, Gajecki L, Qureshy S, et al · · 2026 · PMID 41469157 · DOI 10.2967/jnumed.125.271365 -
Antibody-Based Therapies for Peripheral T-Cell Lymphoma.
Shafagati N, Paul S, Rozati S, Sterling CH. · · 2024 · PMID 39456582 · DOI 10.3390/cancers16203489
Verify or expand the search:
- PubMed search for NCT05994157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Y-mAbs Therapeutics trials
Trials by the same sponsor.
- NCT04315246 — 177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melan · Phase 1, PHASE2 · withdrawn
- NCT05077423 — A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · terminated
- NCT04560166 — Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma · Phase 2 · terminated
- NCT04167618 — 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma · Phase 1, PHASE2 · terminated
- NCT04750239 — Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer · Phase 1, PHASE2 · terminated
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 NCT05994157 (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 Y-mAbs Therapeutics
- Last refreshed: 12 March 2026
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/NCT05994157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing