Full TitlePAC PROTOCOL: 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
The purpose of this study is to find the highest dose of the investigational drug CA-4948 that can be given safely and to evaluate its preliminary anticancer effectiveness in patients with non-Hodgkin lymphoma that has come back or continued to grow despite prior therapy. CA-4948 works by blocking a protein in normal and cancerous B cells (a type of immune cell) called IRAK4, which may promote the growth and survival of B cells in lymphoma. CA-4948 is designed to fight cancer by blocking IRAK4, thereby stopping or reducing the signals that promote lymphoma B-cell survival.
CA-4948 is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have B-cell non-Hodgkin lymphoma that has come back or continued to grow despite prior treatment.
- At least 3 weeks must pass since the completion of prior anticancer drugs, 1 week since any radiation therapy, and 6 months since autologous stem cell transplantation (if received) and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Anas Younes at 212-639-5059.