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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.