CAR-T Followed by Bispecific Antibodies

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04889716
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mosunetuzumab — DRUG
    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.
  • glofitamab — DRUG
    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
  • obinutuzumab — DRUG
    1000 mg IV on Cycle 1 Day 1.

Study Details

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).

Key Dates

Start date
Nov 5, 2021
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
23 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants receive mosunetuzumab 60 mg for cycles 1 and 2 (although fractionated for cycle 1), and 30 mg for all subsequent cycles after standard-of-care therapy with CD19-directed CAR T-cells
  • Experimental: Cohort 2
    Participants receive obinutuzumab (1000 mg for each subject) and glofitamab after standard-of-care therapy with CD19-directed CAR T-cells. The dose of glofitamab for each subject will be 30 mg, other than for cycle 1, which will be 12.5 mg glofitamab fractionated over two weeks.

Primary Outcome Measure

Assessment of the percentage of subjects who achieve a complete metabolic response at 24 weeks from date of first infusion as measured by Cheson 14 (ie Lugano) criteria [ Time Frame: 24 weeks from date of first infusion of investigational agent ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Katie Bourret, RN
[email protected]
402-552-9601
Linda Chee, CRC
[email protected]
Robert Gregory Bociek, MD (SUB_INVESTIGATOR)
Christopher D'Angelo, MD (SUB_INVESTIGATOR)
Julie Vose, MD (SUB_INVESTIGATOR)
Snegha Ananth, MD (SUB_INVESTIGATOR)
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Rachel Lundberg, PA-C
[email protected]
215-615-5858
Kaitlin Kennard, RN
[email protected]
215-615-5858
Stephen J. Schuster, MD (PRINCIPAL_INVESTIGATOR)
Elise A. Chong, MD (SUB_INVESTIGATOR)
Jakub Svoboda, MD (SUB_INVESTIGATOR)

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NEAbramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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