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

NCT04756726 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CFT7455-1101
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 13

Brief 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). Cemsidomide may be administered as a single agent and, in MM only, in combination with oral dexamethasone.

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin's

Keywords

Multiple Myeloma; Lymphoma, Non-Hodgkin's; CFT7455; Relapsed; Refractory

Outcome Measures

Primary Outcomes (6)

• Phase 1: Safety and tolerability of cemsidomide

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

  Baseline through 30 days after the last dose of study treatment

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

  Percent of subjects with AEs with cemsidomide in combination with dexamethasone

  Baseline through 30 days after the last dose of study treatment

• 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

  Days 1-28

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

  Percent of subjects with DLTs with cemsidomide in combination with dexamethasone

  Days 1-28

• 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

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

• 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

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

Study Arms (7)

Phase 1: Arm A - cemsidomide

EXPERIMENTAL

Participants 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.

Drug: cemsidomide

Phase 1: Arm B1 - cemsidomide

EXPERIMENTAL

Participants 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.

Drug: cemsidomide

Phase 1: Arm B2 - cemsidomide in combination with dexamethasone

EXPERIMENTAL

Participants 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

Drug: cemsidomide; Drug: Dexamethasone Oral

Phase 1: Arm C - cemsidomide

EXPERIMENTAL

Participants with r/r NHL will be treated with escalating doses of oral cemsidomide single agent administered according to different dosing schedules in each cohort

Drug: cemsidomide

Phase 2: Arm 1 - cemsidomide

EXPERIMENTAL

Participants with r/r MM will be treated with oral cemsidomide single agent

Drug: cemsidomide

Phase 2: Arm 2 - cemsidomide in combination with dexamethasone

EXPERIMENTAL

Participants with r/r MM treated with oral cemsidomide in combination with oral dexamethasone

Drug: cemsidomide; Drug: Dexamethasone Oral

Phase 2: Arm 3 - CFT7455

EXPERIMENTAL

Participants with r/r peripheral T-cell lymphoma (PTCL) treated with oral cemsidomide single agent

Drug: cemsidomide

Interventions

cemsidomide DRUG

oral cemsidomide

Also known as: CFT7455

Phase 1: Arm A - cemsidomide; Phase 1: Arm B1 - cemsidomide; Phase 1: Arm B2 - cemsidomide in combination with dexamethasone; Phase 1: Arm C - cemsidomide; Phase 2: Arm 1 - cemsidomide; Phase 2: Arm 2 - cemsidomide in combination with dexamethasone; Phase 2: Arm 3 - CFT7455

Dexamethasone Oral DRUG

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

Phase 1: Arm B2 - cemsidomide in combination with dexamethasone; Phase 2: Arm 2 - cemsidomide in combination with dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
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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)

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

Sponsors & Collaborators

• C4 Therapeutics, Inc.: lead

Study Sites (13)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of California-San Francisco

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute (Sarah Cannon Research Institute)

Denver, Colorado, 80218, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of St. Louis

St Louis, Missouri, 63110, United States

Location

Mt Sinai Medical Center

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Tennessee Oncology (Sarah Cannon Research Institute)

Nashville, Tennessee, 37203, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Recurrence

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: April 27, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)