Clinical trial · Interventional
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
NCT05994157CI-TRIAL-00105355terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is terminated by Sponsor decision due to recruitment challenges.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD38-SADA:177Lu-DOTA Complex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD38-SADA:177Lu-DOTA Complex
- interventionNames
- Drug: CD38-SADA:177Lu-DOTA Complex
Primary outcomes (2)
- measure
- Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
- timeFrame
- 4 weeks
- measure
- Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival * The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease * CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory * Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial. Exclusion Criteria: * Primary central nervous system lymphoma or known central nervous system involvement with lymphoma * Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA * Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA * Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA * Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA * \>40% lymphoma bone marrow involvement
References
Publications (0)
Data not yet available
No reference posted for this study.