Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
A Phase Ia/Ib Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma, and as a Single Agent and in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Daratumumab/rHuPH20 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Tiragolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A: Tiragolumab R/R MM
- description
- Participants with relapsed or refractory (R/R) Multiple Myeloma (MM) will receive a single dose of 600 mg tiragolumab by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).
- interventionNames
- Drug: Tiragolumab
- type
- EXPERIMENTAL
- label
- Arm B: Tiragolumab R/R NHL
- description
- Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg tiragolumab by IV infusion Q3W.
- interventionNames
- Drug: Tiragolumab
- type
- EXPERIMENTAL
- label
- Arm C: Tiragolumab + Daratumumab R/R MM
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: General Inclusion Criteria (All Participants): * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of \>/= 12 weeks Inclusion Criteria Specific to Arms A, C and E (R/R MM): * Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies * Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy. * Measurable disease defined by laboratory test results. Inclusion Criteria Specific to Arms B and D (R/R NHL): * Participants with histologically confirmed B-cell NHL who have relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists. * Must have at least one bi-dimensionally measurable lesion. Exclusion Criteria: General Exclusion Criteria (All Participants): * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment * Prior treatment with any anti-TIGIT agent * Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 12 weeks before first study drug administration * Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration * Active or history of autoimmune disease or immune deficiency * Known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration Exclusion Criteria Specific to Arms A, C and E (R/R MM): * Primary or secondary plasma cell leukemia * Current or history of CNS involvement by MM Exclusion Criteria Specific to Arms B and D (R/R NHL): * Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * Current or history of CNS lymphoma * Current eligibility for ASCT Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available