Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
18 Years and older, Male and Female
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,
pharmacodynamics, and antitumor activity of CFT7455 administered orally in subjects with
Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) administered
according to different dosing schedules as a single agent and in combination with
- Be willing and able to provide signed informed consent for the trial.
- Age =18 years at the time of signed consent.
- Have histologically or cytologically-confirmed NHL or MM that is r/r disease and must not be candidates for regimens known to provide clinical benefit to be eligible for the study.
- MM subject must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:
- M-protein =0.5g/dL by Serum Protein Electrophoresis (sPEP) or
- =200mg/24-hour urine collection by Urine Protein Electrophoresis (uPEP) or
- Serum Free Light Chain (FLC) levels >100 mg/L involved light chain and an abnormal kappa/lambda (?/?) ratio in subjects without measurable serum or urine M-protein or
- For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level = 0.50g/dL.
- Prior treatments for MM subjects must have the following:
- Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor a glucocorticoid and an anti-CD38 antibody (induction with or without a bone marrow transplant with or without maintenance therapy is considered one regimen).
- Refractory disease defined as disease that is nonresponsive to therapy (failure to achieve minimal response or development of progressive disease) or disease progression within 60 days from the last dose of their last myeloma therapy.
- NHL subjects must have documented diagnosis of NHL and measurable disease defined by measurable disease (consistent with Lugano classification) defined as at least one lesion that can be accurately measured in at least two dimensions with PET-CT, documented within 4 weeks of their projected cycle one day one (C1D1) visit. Minimum measurement must be >15 mm in the longest diameter.
- 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 with all standard of care therapies available to the subject which, in the assessment of the investigator, may be beneficial to the subject.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- A woman of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/mL and estradiol < 40 pg/mL (<147 pmol/L) must be obtained].
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods specified in the study protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment.
- Agree to having ongoing pregnancy tests during the study and after discontinuation of the study.
- A male participant must have either had a prior vasectomy or agree to use a condom during the treatment period and for at least 90 days after the last dose of study treatment.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials