Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymph… (NCT04756726) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
United States224 participantsStarted 2021-04-27
Plain-language summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of oral cemsidomide (also known as CFT7455) administered at different dosages in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM). Cemsidomide may be administered as a single agent and, in MM only, in combination with oral dexamethasone.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide signed informed consent for the trial.
✓. Age ≥18 years at the time of signed consent.
✓. ECOG Performance Status ≤2.
✓. Have histologically-confirmed NHL or MM that has relapsed from or is refractory to prior therapy, and should not be candidates for regimens known to provide clinical benefit or should have refused such treatment options
✓. Serum M protein ≥0.5g/dL; or
✓. Urine M protein ≥200mg/24-hour; or
✓. For subjects without measurable serum or urine M protein, serum FLC \>100 mg/L and an abnormal (κ/λ) ratio
✓. For subjects with (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50g/dL.
Exclusion criteria
✕. Presence of central nervous system (CNS) disease.
✕. Has received prior radiotherapy within 2 weeks of start of study treatment.
✕. Have active pneumonitis.
✕. Have any of the following:
✕. Have received prior CC92480 (mezigdomide) during the subjects most recent line of therapy
What they're measuring
1
Phase 1: Safety and tolerability of cemsidomide
Timeframe: Baseline through 30 days after the last dose of study treatment
2
Phase 1: Safety and tolerability of cemsidomide in combination with dexamethasone
Timeframe: Baseline through 30 days after the last dose of study treatment
3
Phase 1: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for cemsidomide
Timeframe: Days 1-28
4
Phase 1: MTD or recommended RP2D for cemsidomide in combination with dexamethasone
Timeframe: Days 1-28
5
Phase 2: Antitumor activity of cemsidomide as a single agent
Timeframe: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first
6
Phase 2: Antitumor activity of cemsidomide in combination with dexamethasone
Timeframe: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first
✕. Subjects with a peripheral neuropathy ≥ Grade 2 at screening.
✕. Clinically significant impaired cardiac function or clinically significant cardiac disease, including any of the following:
✕. Thromboembolic event occurring within 3 months of the first dose of cemsidomide. Enrolled subjects must have a risk-based prophylaxis for venous thromboembolism.