An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started

Record status This record was last updated October 2, 2026 (before its estimated October 16, 2026 completion). Its status may not reflect the trial's current state.

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Record History

The 50 most recent of 84 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 19 to 20
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 26 entries
  2. 5 versions Re-verified since Jul 9, 2025, no change to tracked fieldsv79-v83
  3. Primary and study completion dates: Sep 30, 2026 to Oct 16, 2026v78
  4. Study sites: 20 to 19v77
  5. Primary endpoints: 5 to 2
    • Enrollment target: estimated 280 to confirmed 211
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: 25 to 26
    v76
Show 41 earlier versionsHide 41 earlier versions
  1. 3 versions Re-verified since Apr 11, 2024, no change to tracked fieldsv73-v75
  2. Primary and study completion dates: Nov 30, 2024 to Sep 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 20
    v72
  3. Re-verified, no change to tracked fieldsv71
  4. Site details revised at 2 of 22 sitesv70
  5. Site details revised at 3 of 22 sitesv69
  6. Re-verified, no change to tracked fieldsv68
  7. Site details revised at 2 of 22 sitesv67
  8. Site details revised at 4 of 22 sitesv66
  9. Site details revised at 1 of 22 sitesv65
  10. Re-verified, no change to tracked fieldsv64
  11. Site details revised at 1 of 22 sitesv63
  12. Re-verified, no change to tracked fieldsv62
  13. Site details revised at 3 of 22 sitesv61
  14. Site details revised at 2 of 22 sitesv60
  15. Site details revised at 1 of 22 sitesv59
  16. Site details revised at 1 of 22 sitesv58
  17. Site details revised at 2 of 22 sitesv57
  18. Site details revised at 3 of 22 sitesv56
  19. Re-verified, no change to tracked fieldsv55
  20. Site details revised at 2 of 22 sitesv54
  21. Site details revised at 1 of 22 sitesv53
  22. Enrollment target: 140 to 280
    • Eligibility criteria revised
    • Site details revised at 3 of 22 sites
    v52
  23. Site details revised at 3 of 22 sitesv51
  24. Site details revised at 3 of 22 sitesv50
  25. Site details revised at 1 of 22 sitesv49
  26. Study sites: 20 to 22v48
  27. Site details revised at 2 of 20 sitesv47
  28. Site details revised at 2 of 20 sitesv46
  29. Study sites revised (20)v45
  30. Study sites: 19 to 20v44
  31. Phase: Phase 1 to Phase 1/2
    • Study sites: 22 to 19
    v43
  32. Site details revised at 1 of 22 sitesv42
  33. Primary and study completion dates: Aug 23, 2021 to Nov 30, 2024
    • Study sites: 23 to 22
    v41
  34. Site details revised at 4 of 23 sitesv40
  35. Phase: Phase 1/2 to Phase 1
    • Study sites: 19 to 23
    v39
  36. Phase: Phase 1 to Phase 1/2
    • Study sites: 17 to 19
    • Eligibility criteria revised
    v38
  37. Study sites: 13 to 17
    • Interventions: Atezolizumab (Drug), Glofitamab (Drug), Obinutuzumab (Drug), Polatuzumab Vedotin (Drug), Tocilizumab (Drug) to 89Zr-Df-IAB22M2C (Drug), Atezolizumab (Drug), Glofitamab (Drug), Obinutuzumab (Drug), Polatuzumab Vedotin (Drug), Tocilizumab (Drug)
    • Study arms: 2 to 3
    v37
  38. Site details revised at 1 of 13 sitesv36
  39. Site details revised at 2 of 13 sitesv35
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.
Trial Details
NCT Number NCT03533283
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Non-Hodgkins Lymphoma
Related terms Lymphoma, Non-Hodgkin
Enrollment 211 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov