An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- Study HIC#:2000022049
- Last Updated:08/15/2023
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
For more information about this study, including how to volunteer, contact:
- Phone Number: 1-203-752-7835
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact firstname.lastname@example.org, or call +18779788343 for more information.
Trial Purpose and Description
Primary Outcome Measures :
- The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: 12 months ]Toxicity will be graded and recorded according to the NCI CTCAE v4.03.
- Maximum tolerated dose (MTD) of CA-4948 measured by dose-limiting toxicities (DLTs) [ Time Frame: 12 months ]MTD determined by the highest dose level studied at which fewer than 2 out of 6 subjects (<33%) experience a dose limiting toxicity
- Recommended Phase 2 Dose (RP2D) of CA-4948 based on overall tolerability data [ Time Frame: 12 months ]RP2D selected based on overall tolerability data from all patients treated at different dose levels and will not exceed the MTD.
- Males and females greater than or equal to 18 years of age
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Diagnosis of histopathologically confirmed B-cell NHL (as per the World Health Organization [WHO] 2016 classification) including WM/LPL.
- Relapsed or refractory disease (as defined below) for which patients are ineligible for or have exhausted standard therapeutic options that would be considered standard of care
- Active central nervous system (CNS) involvement of their malignancy.
- Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (NOTE: prior sites of radiation will be recorded)
- History of allogeneic stem cell transplant
- Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days prior to start of CA-4948
- Current or planned glucocorticoid therapy, with the following exceptions:
- Doses ≤ 10 mg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CA-4948
- Inhaled, intranasal, intraarticular and topical steroids are permitted
- Use of any investigational agent within 28 days prior to start of CA-4948
- Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy, with the exception of alopecia, that has not resolved to Grade ≤ 1 within 7 days prior to start of CA-4948 unless approved by the Medical Monitor
- Known allergy or hypersensitivity to any component of the formulation of CA-4948 used in this study