Trials / Recruiting
RecruitingNCT04889716
CAR-T Followed by Bispecific Antibodies
Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion. Some patients who join the study will receive mosunetuzumab, other patients later in the study may receive a different experimental drug (glofitamab, in combination with obinutuzumab).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mosunetuzumab | 1 mg IV on Cycle 1 Day 1; 2 mg IV Cycle 1 Day 8; 60 mg IV Cycle 1 Day 15; 60 mg IV on Cycle 2 Day 1 and then 30 mg IV every 21 days beginning Cycle 2 Day 1 through Cycle 17. |
| DRUG | glofitamab | 2.5 mg IV Cycle 1 Day 8; 10 mg IV Cycle 1 Day 15 then 30 mg every 21 days beginning Cycle 2 Day 1 through Cycle 12 |
| DRUG | obinutuzumab | 1000 mg IV on Cycle 1 Day 1. |
Timeline
- Start date
- 2021-11-05
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2021-05-17
- Last updated
- 2026-03-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04889716. Inclusion in this directory is not an endorsement.