Immunotherapy
Roger Williams Medical Center participates in numerous immunotherapy clinical trials which are offered in collaboration with our new onsite immunotherapy Core Lab Facility and Principal Investigators who are known nationally and worldwide for their outstanding work in this field.
These trials may provide a clinically effective anti-tumor response without increasing treatment- related toxicities when conventional therapies have reached their maximum benefit or are no longer effective against a patient’s cancer.
One approach is to recruit the patient’s own anti-tumor activity by taking a small portion of the patient’s T cells (cells of the immune system that fight cancer), activating them so that they multiply many times in culture, and then giving them back to the patient in order to “boost” the patient’s immune system to fight his/her cancer.
We currently offer Phase Ib/II clinical trials using second generation designer T cells in breast, prostate, gastrointestinal and solid tumors. T cells can penetrate virtually every biologic space in our bodies, and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. In these studies patient’s T cells are collected, and then they are modified using gene transfer technology, to allow them to recognize surface proteins on cancer cells (tumor markers), so that they may target their activity more specifically. The target antigen being used for these studies is either carcinoembryonic antigen (CEA) which is predominantly expressed on tumors of the colon, rectum, breast, pancreas and other sites, or PSMA for prostate cancers. These modified cells may also be given locally for patients who have liver metastases as a result of CEA positive cancers.
Other studies use a process called the “arming” of T cells. This involves coating the patient’s expanded T cells with a bispecific antibody, which binds one end to the T cells and has another end that recognizes certain molecules that are on the surface of cancer cells. The patient’s T cells are then redirected to specifically target and attack cancer cells once infused back into patient.
The Cancer Immunotherapy Program is built upon a translational research laboratory. Our basic and clinical laboratory team is experienced in developing, producing and testing the safety and efficacy of investigational new biologic therapies in preclinical research and FDA- reviewed clinical trials. Since its establishment in 1999 and enrollment of the first clinical trial patient in 2001, the Cancer Immunotherapy Program has continued to enroll patients into various FDA reviewed and RWMC Internal Review Board approved immunotherapy clinical trials.
IMMUNOTHERAPY PROTOCOLS
MM-001: A Phase 1 Study of Anti-CD38 CAR-T Therapy in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Principle Investigator: Todd Roberts, MD
Eligibility Criteria:
Population 1:
Adults with RRMM after receiving at least the following:
- Lenalidomide (Revlimid®)
- Pomalidomide (Pomalyst®)
- Bortezomib (Velcade®)
- Carfilzomib (Kyprolis®)
- Daratumumab (Darzalex®)
Or
Population 2:
Adults with RRMM within 1 year of receiving Autologous Stem Cell Transplant and:
- Measurable Disease
- No myeloma involvement of the central nervous system,
- brain metastasis, or spinal cord compression
- No active plasma cell leukemia
- Good performance status
Contact Information:
Alexandra Milhaupt BSN, RN
Immunotherapy Nurse Coordinator
Office of Therapeutic Development
Phone: (401) 456-2526
alexandra.milhaupt@CharterCARE.org
CEA-001: A Phase 1 Study of Anti-CEA CAR-T Therapy for Patients with Pancreatic Cancer Liver Metastases
Principle Investigator: Steven Katz, MD, FACS
Eligibility Criteria:
- Tumor must be CEA-expressing (CEA >10)
- Liver metastases must be documented
- Failed at least one line of standard chemotherapy
- Good performance status
Contact Information:
Gabrielle Masse BSN, RN
Immunotherapy Clinical Research Nurse
Office of Therapeutic Development
Phone: 401-456-2659
gabrielle.masse@chartercare.org
RWMC-IPC 001 Peritoneal Carcinomatosis or Malignant Ascites (RWH 340-74)
Phase 1 Trial of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment in Patients with CEA+-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites. (RWH 340-74)
Contact Information
(All team members listed below are located at Roger Williams Medical Center, 825 Chalkstone Avenue, Providence, RI 02908)
Ashley Moody, BSN, RN (Immunotherapy Research Nurse Manager)
401-456-2268
Email: alarkin@chartercare.org
Alexandra Milhaupt, BSN, RN (Immunotherapy Nurse)
401-456-2526
Email: alexandra.milhaupt@chartercare.org
Catherine Conley, BS (Immunotherapy Research Data Collection Manager)
401-456-2397
Email: Catherine.conley@chartercare.org