Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Thomas Martin
Headshot of Thomas Martin
Thomas Martin

Description

Summary

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 dexamethasone.

Official Title

A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of CFT7455 in Subjects With Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

Keywords

Multiple Myeloma, Lymphoma, Non-Hodgkin's, CFT7455, Relapsed, Refractory, Lymphoma, Plasma Cell Neoplasms, Non-Hodgkin Lymphoma, Dexamethasone, Dexamethasone Oral

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Be willing and able to provide signed informed consent for the trial.
  2. Age ≥18 years at the time of signed consent.
  3. 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.
  4. 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 (κ/λ) 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

You CAN'T join if...

  1. Presence of central nervous system (CNS) disease.
  2. Has received prior radiotherapy within 2 weeks of start of study treatment.
  3. Have active pneumonitis.
  4. 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
    • Primary CNS lymphoma
    • B-cell or T-cell prolymphocytic leukemia
  5. Subjects with a peripheral neuropathy ≥ Grade 2.
  6. Known malignancy other than study indication that is progressing or has required treatment within the past three years.
  7. Received live, attenuated vaccine within four weeks of first dose.
  8. Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
  9. Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc) antigen.

    10. Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of

    viral load. If hepatitis C antibody test is positive, a confirmatory test should be performed. If the test is negative, subject is eligible for this trial.

    11. Concurrent administration of strong CYP3A modulators. 12. Is pregnant, breastfeeding, or expecting to conceive or father children within the

    projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

    13. Subjects on proton pump inhibitors (PPIs). The last dose of PPIs must be administered

    seven days prior to administration of study drug. Antacids are acceptable when administered in a staggered dosing manner with CFT7455.

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Mayo Clinic accepting new patients
    Phoenix Arizona 85054 United States

Lead Scientist at UCSF

  • Thomas Martin
    A leading expert in hematology-oncology, Dr. Thomas Martin is associate director of UCSF's myeloma program and director of the unrelated donor transplantation programs for adults at UCSF Medical Center. Martin is clinical research director of hematologic malignancies (blood cancers) at the UCSF Helen Diller Family Comprehensive Cancer Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
C4 Therapeutics, Inc.
ID
NCT04756726
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 158 study participants
Last Updated