Safety and efficacy of mosunetuzumab or glofitamab with CC-220 or CC-99282 in patients with NHL
Research type
Research Study
Full title
A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB OR GLOFITAMAB IN COMBINATION WITH CC-220 AND CC-99282 IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA
IRAS ID
1005230
Contact name
Head, EU/International / RA Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-005745-33
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn more about the safety, efficacy and pharmacokinetics (the activity of drugs in the body over a period of time) of two combinations (Arms) of investigational drugs in patients (18 years and over) who have a type of cancer called Non-Hodgkin Lymphoma (NHL). Arm 1 - mosunetuzumab in combination with CC-220 and CC-99282 (CELMoDs), Arm 2 - Glofitamab in combination with CELMoDs. Many NHL patients have disease that stops responding to treatment and comes back. This study will investigate new possible treatments for these patients with the goal to increase progression-free and overall survival.
About 64-112 people will take part in this study and taking part is entirely voluntary. Participants will receive a total of 12 cycles of study treatment, the cycle duration is 21 days for cycle 1 and 28 days for cycles 2-12 for Arm 1 and is 21 days for Arm 2. After, follow-up visits will be every 3 months for 2 years.
The study will include an initial dose-escalation phase, comprised of cohorts of 3-9 participants. This is where participants will be given increasing doses of CC-220 or CC-99282 to determine the Recommended Phase II Dose (RP2D – highest dose with acceptable toxicity) in their respective treatment combinations (see below).
The initial dose-escalation phase will be followed by an expansion phase in which the RP2D for CC-220 or CC-99282 will be given. Expansion Cohorts will enrol approximately 20 participants per cohort. The expansion phase is designed to further assess the safety and efficacy of mosunetuzumab + CELMoDs (at the RP2D) and glofitamab and CELMoDs (at the RP2D).
Treatment combinations:
Arm 1 - Dose Escalation: Mosunetuzumab + CC-220 (1 to 2 cohorts) / Mosunetuzumab + CC-99282 (1 to 2 cohorts). Dose Expansion: Mosunetuzumab + CC-220 or C-99282 (1 cohort)
Arm 2 - Dose Escalation: Glofitamab + CC-220 (1-2 cohorts) / Glofitamab + CC-99282 (1-2 cohorts). Dose Expansion: Glofitamab + CC-220 or C-99282 (1 cohort)REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0118
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion