Phase
Condition
Red Blood Cell Disorders
Non-hodgkin's Lymphoma
Multiple Myeloma
Treatment
CFT7455
cemsidomide
Dexamethasone Oral
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 toprior therapy, and should not be candidates for regimens known to provide clinicalbenefit 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 anabnormal (κ/λ) ratio
For subjects with (IgA), myeloma whose disease can only be reliably measured byquantitative 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 lastdose 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 measurabledisease (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-basedchemotherapy. 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 andalkylator chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.
Follicular Lymphoma: ≥2 lines of therapy, including CD20 antibody therapy andalkylator chemotherapy.
Diffuse Large B-cell Lymphoma: ≥2 lines of therapy, including prior CD20antibody therapy, and has received prior autologous bone marrow transplant (oris ineligible for bone marrow transplant).
Other NHL: Subjects must have been treated or refused treatment with anystandard of care therapies known to provide clinical benefit.
- In Phase 2, only subjects with the following indications will be eligible for theappropriate 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 withrelapsed refractory disease following 1 prior line of therapy containingalkylator-based chemotherapy will be included. Subjects with ALCL must have hadprior exposure to anti CD30 antibody as part of their prior treatment regimen.
Have provided archival tumor tissue sample or newly obtained core or excisionalbiopsy of a tumor lesion (lymph node or extra-nodal infiltration of a tissue for NHLsubjects, bone marrow aspirate and biopsy for MM subjects) and for Adult T-cellleukemia/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 tumorinfiltration 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 (subjectreceiving anticoagulant therapy must be on a stable regimen)
- Female subjects may not be pregnant or intend to become pregnant, may not breastfeedor intend to breastfeed, or donate ova, and must satisfy one of the followingconditions:
A woman of childbearing potential (WOCBP) must agree to use highly effectivecontraception during study participation and 30 days after the completion of studytreatment.
A woman on hormone replacement therapy (HRT) and whose menopausal status is indoubt will be required to use one of the contraception methods specified if theywish to continue their HRT during the study
A woman of non-childbearing potential (i.e., physiologically incapable of becomingpregnant) or postmenopausal
A male subject must agree to use a condom when having intercourse with a person ofchild bearing potential during the treatment period and for at least 30 days afterthe last dose of study treatment.
Males must refrain from donating sperm during the treatment period and for 30 daysafter the last dose of study treatment.
Subjects must refrain from donating blood during study treatment and for 30 daysafter discontinuation.
Exclusion
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:
Non-secretory or oligosecretory MM
Plasma cell leukemia
Systemic light chain amyloidosis
Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skinchanges (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 oftherapy
Subjects with a peripheral neuropathy ≥ Grade 2 at screening.
Clinically significant impaired cardiac function or clinically significant cardiacdisease, including any of the following:
Clinically significant and/or uncontrolled heart disease such as congestiveheart failure requiring treatment (NYHA ≥Grade 2), uncontrolled hypertension,or clinically significant arrhythmia.
Interval corrected according to Friderica's correction (QTcF) >480 msec onscreening ECG.
Acute myocardial infarction or unstable angina pectoris within 6 months priorto 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 requiredtreatment 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 isrequired unless mandated by local health authority.
Any Subject with a known history of, or considered at risk for, Hepatitis Binfection 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 foranti-HCV antibodies. If anti-HCV antibodies are present or there is prior history ofHCV treatment, HCV RNA must be undetectable.
Uncontrolled active systemic infection or any life-threatening illness, medicalcondition, or organ system dysfunction which, in the investigator's opinion, couldcompromise 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. StrongCYP3A inhibitors and inhibitors of MDR1 and BCFP must be discontinued 5 half-livesbefore 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 investigationalagent, or has used an investigational treatment within ≤ 5 half-lives or within 4weeks (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 affectinggastrointestinal function.
Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound results of the study, interfere with the subject'sparticipation for full duration of the study, or is not in the best interest of thesubject to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere withcooperating with requirements of the study.
Previously identified hypersensitivity to components of the study treatment orexcipients.
Study Design
Connect with a study center
Mayo Clinic
Phoenix, Arizona 85054
United StatesSite Not Available
Mayo Clinic
Phoenix 5308655, Arizona 5551752 85054
United StatesSite Not Available
University of California-San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of California-San Francisco
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Colorado Blood Cancer Institute (Sarah Cannon Research Institute)
Denver, Colorado 80218
United StatesSite Not Available
Colorado Blood Cancer Institute (Sarah Cannon Research Institute)
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Washington University School of St. Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of St. Louis
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Mt Sinai Medical Center
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Mt Sinai Medical Center
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Levine Cancer Institute - Charlotte
Charlotte, North Carolina 28204
United StatesSite Not Available
Tennessee Oncology (Sarah Cannon Research Institute)
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology (Sarah Cannon Research Institute)
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
The University of Texas - MD Anderson
Houston, Texas 77030
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available
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