A Study of CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label trial to evaluate oral administration of CA-4948 in adult
patients with relapsed/refractory hematologic malignancies. Part A will evaluate escalating
doses of CA-4948 either as monotherapy (Part A1) or in combination with ibrutinib for non-
Hodgkin's Lymphoma (NHL), macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) and chronic
lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (Part A2). Once the combination
dose has been determined, Part B will comprise an expansion phase to assess efficacy (CR
rate) and safety of the RP2D of CA-4948 and ibrutinib in 4 Non-Hodgkin Lymphoma (NHL)
disease-specific cohorts:
- Cohort 1 - Marginal zone lymphoma (MZL)
- Cohort 2 - activated B-cell (ABC) diffuse large B-cell lymphoma (DLBCL) or extranodal
subtypes: Leg-, testicular-, or not otherwise specified (NOS)-type
- Cohort 3 - Primary central nervous system lymphoma (PCNSL)
- Cohort 4 - Patients receiving ibrutinib monotherapy who have developed adaptive,
secondary resistance. Indications include:
- Mantle Cell Lymphoma (MCL), MZL, CLL/SLL, or WM/LPL
- Indications for which ibrutinib is National Comprehensive Cancer Network
(NCCN)-listed (e.g., PCNSL)
- Patients with NHL and known myddosome mutations
- Patients may be candidates for maintaining ibrutinib while CA-4948 will be added
for resistance reversal. A brief gap of ibrutinib therapy of <3 weeks is
acceptable.