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Multiple MyelomaPhase 1NCT04756726

Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

A Phase 1 study testing cemsidomide and Dexamethasone Oral in people with Multiple Myeloma and Lymphoma, Non-Hodgkin's, run by C4 Therapeutics, Inc. at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Lymphoma, Non-Hodgkin's
What is being tested?
cemsidomide and Dexamethasone Oral
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
13 sitesUnited States
Study dates
27 Apr 2021to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • MM subjects must have:
  • Measurable disease at baseline defined as:
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  • 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.
  • Received at least 3 prior treatment regimens including lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and an anti-CD38 antibody.
  • Refractory to, or had documented disease progression within 60 days from the last dose of their prior MM treatment (or, if the last MM therapy was with CAR-T cells, documented disease progression any time after administration).
  • NHL subjects must have:
  • Documented diagnosis of NHL and measurable disease defined by measurable disease (consistent with Lugano classification)
  • NHL subjects must have received the following regarding prior therapy:
  • Peripheral T-cell Lymphoma: At least one prior line containing alkylator-based chemotherapy. Note: For subjects with Anaplastic Large Cell Lymphoma (ALCL), the subject must also have received CD30 antibody therapy.
  • Mantle Cell Lymphoma: ≥2 lines of therapy, including CD20 antibody and alkylator chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.
  • Follicular Lymphoma: ≥2 lines of therapy, including CD20 antibody therapy and alkylator chemotherapy.
  • Diffuse Large B-cell Lymphoma: ≥2 lines of therapy, including prior CD20 antibody therapy, and has received prior autologous bone marrow transplant (or is ineligible for bone marrow transplant).
  • Other NHL: Subjects must have been treated or refused treatment with any standard of care therapies known to provide clinical benefit.
  • In Phase 2, only subjects with the following indications will be eligible for the appropriate expansion arm:
  • Relapsed/refractory MM (as defined in Phase 1 of the study).
  • Relapsed/refractory T-cell NHL including: PTCL, PTCL-NOS, AITL and ALCL with relapsed refractory disease following 1 prior line of therapy containing alkylator-based chemotherapy will be included. Subjects with ALCL must have had prior exposure to anti CD30 antibody as part of their prior treatment regimen.
  • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (lymph node or extra-nodal infiltration of a tissue for NHL subjects, bone marrow aspirate and biopsy for MM subjects) and for Adult T-cell leukemia/lymphoma (ATLL) subjects [if applicable], not previously irradiated.
  • Subjects need to have adequate organ function defined as follows to include:
  • ANC ≥1.0 x 109/L
  • Platelets ≥75,000 cells/µL
  • Hemoglobin ≥8.0 g/dL
  • ALT and AST ≤3.0 x upper limit of normal (ULN); except for subjects who have tumor infiltration of the liver, where ALT or AST ≤5 x ULN.
  • Total bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome).
  • CrCl ≥40 mL/min
  • International normalized ratio (INR) <1.5 x ULN and aPTT <1.5 x ULN (subject receiving anticoagulant therapy must be on a stable regimen)
  • Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova, and must satisfy one of the following conditions:
  • A woman of childbearing potential (WOCBP) must agree to use highly effective contraception during study participation and 30 days after the completion of study treatment.
  • A woman on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods specified if they wish to continue their HRT during the study
  • A woman of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or postmenopausal
  • A male subject must agree to use a condom when having intercourse with a person of child bearing potential during the treatment period and for at least 30 days after the last dose of study treatment.
  • Males must refrain from donating sperm during the treatment period and for 30 days after the last dose of study treatment.
  • Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

Who cannot join

  • 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:
  • Non-secretory or oligosecretory MM
  • Plasma cell leukemia
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  • Systemic light chain amyloidosis
  • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
  • Lymphoblastic lymphoma
  • Mycosis fungoides
  • Sezary syndrome
  • Primary cutaneous T-cell lymphomas
  • B-cell or T-cell prolymphocytic leukemia
  • Chronic lymphocytic lymphoma/small cell lymphoma
  • Richter's transformation
  • Burkitt lymphoma
  • Myelodysplastic syndrome
  • 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:
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA ≥Grade 2), uncontrolled hypertension, or clinically significant arrhythmia.
  • Interval corrected according to Friderica's correction (QTcF) >480 msec on screening ECG.
  • Acute myocardial infarction or unstable angina pectoris within 6 months prior to study entry.
  • Thromboembolic event occurring within 3 months of the first dose of cemsidomide. Enrolled subjects must have a risk-based prophylaxis for venous thromboembolism.
  • Known malignancy other than study indication that has progressed or has required treatment within the past 3 years.
  • Major surgery within 2 weeks of the first dose of study treatment.
  • Presence of ≥Grade 2 toxicity (CTCAE v5.0) due to prior cancer therapy.
  • Received live, attenuated vaccine within four weeks of first dose.
  • Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
  • Any Subject with a known history of, or considered at risk for, Hepatitis B infection must be tested. Subjects will be excluded if Hepatitis B surface antigen (HBS-Ag) is detected
  • Any Subject with a known history or risk of Hepatitis C virus must test negative for anti-HCV antibodies. If anti-HCV antibodies are present or there is prior history of HCV treatment, HCV RNA must be undetectable.
  • Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
  • Concurrent administration of strong CYP3A modulators (inducers or inhibitors, including certain foods) and inhibitors of MDR1 (p-glycoprotein) and BCRP. Strong CYP3A inhibitors and inhibitors of MDR1 and BCFP must be discontinued 5 half-lives before the first dose of study drug, and strong CYP3A inducers must be discontinued 14 days prior to the first dose of study drug.
  • Is currently participating in, or has participated in, a study of an investigational agent, or has used an investigational treatment within ≤ 5 half-lives or within 4 weeks (whichever is shorter) prior to the first dose of study treatment.
  • Inability or difficulty swallowing capsules, or tablets (as available), malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound results of the study, interfere with the subject's participation for full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperating with requirements of the study.
  • Previously identified hypersensitivity to components of the study treatment or excipients.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Colorado Blood Cancer Institute (Sarah Cannon Research Institute)

    Denver, Colorado, 80218

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology (Sarah Cannon Research Institute)

    Nashville, Tennessee, 37203

  • Mt Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California-San Francisco

    San Francisco, California, 94143

  • Washington University School of St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of CFT7455 in Subjects With Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

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.

Being tested
cemsidomide, Dexamethasone Oral
Keywords
Multiple Myeloma, Lymphoma, Non-Hodgkin's, CFT7455, Relapsed, Refractory
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cemsidomideDrug

    Also called CFT7455

    oral cemsidomide

  • Dexamethasone OralDrug

    oral dexamethasone [ ≤75 years old: 40 mg once per week (QW) on days 1, 8, 15, and 22; >75 Years old: 20 mg QW on days 1, 8, 15, and 22]

Study groups in NCT04756726
Study groupRoleWhat they receive
Phase 1: Arm A - cemsidomideExperimentalParticipants with r/r NHL or r/r MM will be treated with oral cemsidomide as a single agent administered at different dosages and dosing schedules.
Receives: Drug: cemsidomide
Phase 1: Arm B1 - cemsidomideExperimentalParticipants with r/r MM will be treated with escalating doses of oral cemsidomide as a single agent administered at different dosages and dosing schedules in each cohort, until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or Sponsor discretion.
Receives: Drug: cemsidomide
Phase 1: Arm B2 - cemsidomide in combination with dexamethasoneExperimentalParticipants with r/r MM will be treated with escalating doses of oral cemsidomide in combination with a fixed dose of oral dexamethasone in each cohort
Receives: Drug: cemsidomide; Drug: Dexamethasone Oral
Phase 1: Arm C - cemsidomideExperimentalParticipants with r/r NHL will be treated with escalating doses of oral cemsidomide single agent administered according to different dosing schedules in each cohort
Receives: Drug: cemsidomide
Phase 2: Arm 1 - cemsidomideExperimentalParticipants with r/r MM will be treated with oral cemsidomide single agent
Receives: Drug: cemsidomide
Phase 2: Arm 2 - cemsidomide in combination with dexamethasoneExperimentalParticipants with r/r MM treated with oral cemsidomide in combination with oral dexamethasone
Receives: Drug: cemsidomide; Drug: Dexamethasone Oral
Phase 2: Arm 3 - CFT7455ExperimentalParticipants with r/r peripheral T-cell lymphoma (PTCL) treated with oral cemsidomide single agent
Receives: Drug: cemsidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Safety and tolerability of cemsidomide

    Percent of subjects with adverse events (AEs) with cemsidomide as a single agent

    Measured: Baseline through 30 days after the last dose of study treatment

  2. Phase 1: Safety and tolerability of cemsidomide in combination with dexamethasone

    Percent of subjects with AEs with cemsidomide in combination with dexamethasone

    Measured: 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

    Percent of subjects with dose-limiting toxicities (DLTs) with cemsidomide as a single agent

    Measured: Days 1-28

  4. Phase 1: MTD or recommended RP2D for cemsidomide in combination with dexamethasone

    Percent of subjects with DLTs with cemsidomide in combination with dexamethasone

    Measured: Days 1-28

  5. Phase 2: Antitumor activity of cemsidomide as a single agent

    Overall Response Rate (ORR) based on Best Overall Response (BOR), Duration of Response (DOR), and Progression Free Survival (PFS) of cemsidomide

    Measured: 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

    ORR based on BOR, DOR, and PFS of cemsidomide in combination with dexamethasone in subjects with MM based on International Myeloma Working Group (IMWG) criteria

    Measured: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start27 Apr 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756726
Sponsor's protocol ID
CFT7455-1101
Status last verified
Mar 2026
First submitted
12 Feb 2021
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cemsidomide and Dexamethasone Oral in people with Multiple Myeloma and Lymphoma, Non-Hodgkin's, run by C4 Therapeutics, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Safety and tolerability of cemsidomide (time frame: Baseline through 30 days after the last dose of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04756726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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Clinical Trial NCT04756726 | AzTrials