Mount Sinai is a leader in immunotherapy research and clinical applications for cancer.
Immunotherapy uses the power of your immune system to attack cancer. It has become a significant component of cancer treatment and is bringing breakthrough treatments to increasing numbers of patients for improved outcomes and sustained remissions.
A New Approach to Immunotherapy: How CAR T Cells Help Fight Cancer
As cancer progresses, your immune system may become more and more compromised. This can contribute to rapid tumor growth. Our Cancer Immunology Research Program identifies what makes it difficult for the immune system to defend itself against tumors. Once we identify these mechanisms, we can better develop novel immunotherapies to kill cancer cells.
Adoptive Cell Therapy (ACT)
We use an advanced form of immunotherapy called adoptive cell therapy (ACT) to treat cancer. ACT uses your own T cells (immune cells) to treat your cancer. CAR T-cell therapy, a type of adoptive cell transfer, has dramatically helped some patients who have not benefited from other treatments.
The Living Drug
When we use CAR T-cell therapy, we start by drawing blood and separating out the T cells. Then we genetically engineer the T cells to produce receptors on their surface called chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein, or antigen, on cancer cells. Once these cells can express the antigen-specific CAR, we expand them, in the laboratory, into the hundreds of millions. Finally, following a chemotherapy regimen, we infuse the CAR T cells back into you. The engineered CAR T cells function as a living drug that is designed to further multiply in your body and recognize and kill cancer cells that contain the antigen on their surfaces.
This video from the National Cancer Institute (NCI) explains how immunotherapy works.
Immunotherapy Clinical Trials
We use CAR T-cell and innovative immunotherapies to treat various cancers through the Cellular Therapy Service at The Tisch Cancer Institute.
We were among the first institutions to participate in clinical trials that use CAR T cells for multiple myeloma. Our experience began with Celgene’s Phase 1 bb2121 CRB-401 dose escalation and dose expansion study. Mount Sinai was one of only nine sites participating in this trailblazing CAR T-cell study. Results were reported in the New England Journal of Medicine.
Mount Sinai was one of the first two institutions to conduct First in Human Trial with Janssen/Legend Biotechnology CAR T-cell therapy. The study has crossed the safety threshold and is accruing patients to determine efficacy.
Clinical trials that use CAR T cells for multiple myeloma:
Our experience with CAR T-cell therapy for multiple myeloma began with Celgene’s Phase 1 bb2121 CRB-401 dose escalation and dose expansion study. Mount Sinai was one of only nine sites participating in this trailblazing CAR T-cell study. Results were reported at the 2017 annual meeting of the American Hematology Society.
- Mount Sinai is one of only nine study sites in the U.S. and the only site in New York State to participate in a Phase 2 trial—known as the KarMMa study—designed to secure approval for the first CAR T-cell therapy targeting multiple myeloma for relapsed/refractory patients.
Immunotherapy Clinical Trials for Relapsing/Refractory Myeloma Open to Patient Enrollment
CAR T-cell Therapy
- A Phase 2, Multi-Cohort, Open-Label Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects with Clinical High-Risk Multiple Myeloma
GCO# 40-5076, ClinicalTrials.gov Identifier: NCT03601078
- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of bb2121 Vs Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma
GCO# 40-5083 ClinicalTrials.gov Identifier: NCT03651128
- A Phase 1, Open-Label, Dose-Escalation, PK, PD Study of the Safety and Efficacy of CAR2 Anti-CD38 A@ CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma
GCO# 19-0814, ClinicalTrials.gov Identifier: NCT03464916
- A Phase 1 Study of bb21217, an anti-BCMA CAR T Cell Drug Product in Relapsed and/or Refractory Multiple Myeloma
GCO# 17-1910, ClinicalTrials.gov Identifier: NCT03274219
- A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma
GCO# 18-1068, ClinicalTrials.gov Identifier: NCT03548207
- A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized GPRC5D x CD3 DuoBody® Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
GCO# 17-2163,ClinicalTrials.gov Identifier: NCT03399799
- A Phase 1, First-in-Human, Open-Label Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
GCO# 18-1068, ClinicalTrials.gov Identifier: NCT03145181
- A Phase I/2 FIH Study of REGN5458 (Anti-BCMA X ANTI-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma
GCO# 19-0138, ClinicalTrials.gov Identifier: NCT03761108
- A Phase 1, First-in-Man, Multicenter, Open-Label, Two Part Dose-Escalation and Cohort Expansion Study of Single-Agent GBR 1342 in Subjects with Previously Treated Multiple Myeloma
GCO# 18-1328, ClinicalTrials.gov Identifier: NCT03309111
For information about immunotherapy clinical trials for multiple myeloma, contact Lisa La at Lisa.La@mssm.edu or 212-241-7873.