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

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma, Lymphoma, Non-Hodgkin's

In brief

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.

Key facts

Study ID: NCT04756726
Run by: C4 Therapeutics, Inc.
People needed: 224
Starts: 2021-04-27
Expected to finish: 2026-12-31
Last updated by the study team: 2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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.

You may not qualify if…

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
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.

Where it is running

Mayo Clinic — Phoenix, Arizona, United States
University of California-San Francisco — San Francisco, California, United States
Colorado Blood Cancer Institute (Sarah Cannon Research Institute) — Denver, Colorado, United States
Mayo Clinic — Jacksonville, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of St. Louis — St Louis, Missouri, United States
Mt Sinai Medical Center — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Tennessee Oncology (Sarah Cannon Research Institute) — Nashville, Tennessee, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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