CFT7455-1101 Study

What is the CFT7455-1101 study?

The CFT7455-1101 clinical research study is for people who have Relapsed/Refractory (r/r) Non-Hodgkin’s Lymphoma (NHL) or Multiple Myeloma (MM). The purpose of this study is to find out if study treatment with the study medication as a single agent or in combination with dexamethasone has any good effects in people with r/r MM or NHL.

There are two parts to this study.  The first part, also known as the “dose escalation part,” tests different doses of study medication to see how much study medication patients can safely receive. In this part of the study, the main goal will be to find the highest dose that can be tolerated safely and the appropriate dosing schedule of the study medication as a single agent or in combination with dexamethasone and determine what dose and schedule will be used in the second part of the study.

The second part of the study, also known as the “dose expansion part,” will test the dose and the dosing schedule of the study drug, either as a single agent or in combination with dexamethasone that was determined to be best in the first part of the study.  In this second part of the study, we will continue to see if, at this dose, patients continue to safely tolerate the study medication as a single agent or in combination with dexamethasone.  We will also see how patients’ tumors respond.

Who can join the CFT7455 study?

Study participants may be able to join the study if they meet the following requirements:

• 18 years of age or older
• Have  Non-Hodgkin’s Lymphoma (NHL) or Multiple Myeloma (MM) that is relapsed/refractory which is defined as disease that is nonresponsive to therapy
• Can provide a previously collected tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
• MM or NHL must not be present in the central nervous system (CNS)
• Must not have received prior radiotherapy within 2 weeks of start of study treatment.
• Must not have impaired cardiac function or clinically significant cardiac disease
• In addition to the disease specific requirements:

Multiple Myeloma Requirements:

• Patients must have a documented diagnosis of MM and measurable disease at enrollment
• Received at least 3 prior anti-myeloma regimens

Non-Hodgkin's Lymphoma Requirements:

• Patients must have documented diagnosis of NHL and measurable disease
• NHL patients must have received the following regarding prior therapy:

• Peripheral T-cell Lymphoma: At least one prior line of therapy.
• Mantle Cell Lymphoma: ≥2 prior lines of therapy
• Follicular Lymphoma: ≥2 prior lines of therapy.
• Diffuse Large B-cell Lymphoma: ≥2 prior lines of therapy.
• Other NHL: Patients 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.

*Other study requirements will apply. Talk to your doctor about participating in this study.

What will happen during the study?

Participation in the CFT7455-1101 research study lasts about 14 weeks. NHL & MM study participants can expect the following:

1. Review & sign the Informed Consent Form
2. Screening period (4 weeks with 1* clinic visit): Receive study health assessments to confirm if you qualify for the study.
3. Study Treatment period (Duration dependent on how many cycles you complete): Depending upon the group you are assigned to, you will receive treatment once a day for 21, 14, or 7 days administered orally**

• Cycle 1:  28 days (3-6 clinic visits )
• Cycle 2: 28 days (2 clinic visits)
• Cycle 3: 28 days (2 clinic visits)
• Cycles 4+: 28  days (1 clinic visit)

4. Follow-up period (4 weeks): Receive study health assessments. (1 clinic visit)

*Screening may occur over multiple clinic visits.

**Schedule of assessments and clinic visits vary based on a study participant’s assigned dosing schedule

Participation in a clinical research study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.