For Leukemia
- Trial 23-197: A phase 1/2, dose-exploration and dose-expansion study evaluating the safety and efficacy of multiplex base-edited, allogeneic anti-CD7 CAR-T cells (BEAM-201) in relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL)
Principal Investigator: Susanne Baumeister, MD - Trial 23-351: A phase 1/2a, open-label, dose escalation, and dose expansion study to assess the safety and efficacy of GDX012 in patients with relapsed or refractory acute myeloid leukemia
Principal Investigator: Evan Chen, MD - Trial 23-287: Arm 1: A phase 1 study of monovalent CD123-specific adapter (SPRX002) and universal CAR-modified T cell (ARC-T Cells) for the treatment of patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndromes
Principal Investigator: Evan Chen, MD - Trial 20-562: A phase 1, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL)
Principal Investigator: Daniel DeAngelo, MD, PhD - Trial 18-233: A phase 1, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor), administered in patients with relapsed/refractory acute myeloid leukemia, and patients with newly diagnosed high-risk acute myeloid leukemia
Principal Investigator: Daniel DeAngelo, MD, PhD - Trial 23-534: A phase 1 study of cytokine-induced memory-like (CIML) NK cells with venetoclax as consolidation therapy in AML
Principal Investigator: Maximillian Stahl, MD
For more information, contact our Adult Leukemia Program.
For Lymphoma
- Trial 23-365: An open-label, multicenter phase 2 study evaluating the efficacy and safety of CRG-022, a CD22-directed autologous chimeric antigen receptor (CAR) T-cell therapy in participants with relapsed/refractory large B-cell lymphoma after CD19-directed CAR T-cell therapy
Principal Investigator: Caron Jacobson, MD, MMSc - Trial 23-086: A phase 1/2 multi-center study to evaluate the safety and efficacy of ONCT-808 in adult subjects with relapsed or refractory aggressive B-cell malignancies
Principal Investigator: Caron Jacobson, MD, MMSc - Trial 22-467: An adaptive phase 3, randomized, open-label, multicenter study to compare the efficacy and safety of axicabtagene ciloleucel versus standard of care therapy as first-line therapy in subjects with high-risk large B-cell lymphoma
Principal Investigator: Caron Jacobson, MD, MMSc - Trial 22-271: A phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in patients with relapsed/refractory follicular lymphoma
Principal Investigator: Caron Jacobson, MD, MMSc - Trial 21-124: A multicenter single arm phase 2 study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in patients with relapsed and/or refractory diffuse large B-cell lymphoma
Principal Investigator: Caron Jacobson, MD, MMSc
For more information, contact our Adult Lymphoma Program.
For Multiple Myeloma
- Trial 22-546: CAR-PRISM (precision intervention smoldering myeloma): A chimeric antigen receptor T cell (CAR-T) therapy directed against BCMA in high-risk smoldering myeloma
Principal Investigator: Irene Ghobrial, MD - Trial 22-533: A phase 2 study of CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (ARC112A, iMMagine-1)
Principal Investigator: Adam Sperling, MD, PhD - Trial 20-120: A phase 1 study of autologous memory-like natural killer (NK) cell immunotherapy in combination with KP1237 and low-dose IL-2 as early post-autologous transplant consolidation in minimal residual disease positive, newly diagnosed multiple myeloma patients
Principal Investigator: Giada Bianchi, MD
For more information, contact our Multiple Myeloma Program.
For Solid Tumors
- Trial 23-278: A phase 1 study to assess the safety and efficacy of LYL845 in adults with relapsed and/or refractory metastatic or locally advanced melanoma and selected solid tumor malignancies
Principal Investigator: Elizabeth Buchbinder, MD - Trial 23-314: A phase 1 dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic solid tumors
Principal Investigator: Antonio Giordano, MD, PhD - Trial 23-374: A phase 1/2, open-label, multicenter, dose escalation and cohort expansion study of the safety and efficacy of anti-CD70 allogeneic CRISPR-Cas9-engineered T cells (CTX131) in adult subjects with relapsed or refractory solid tumors
Principal Investigator: Wenxin Xu, MD - Trial 23-583: A phase 2 trial of PD-L1 t-haNK, N-803 IL-15 superagonist (Anktiva), and cetuximab for immunotherapy-treated patients with advanced HNSCC (QUILT-505)
Principal Investigator: Glenn Hanna, MD - Trial 23-317: An open-label, phase 1, multicenter study to evaluate the safety and preliminary anti-tumor activity of NT-175 in human leukocyte antigen-A*02:01-positive adult subjects with unresectable, advanced, and/or metastatic solid tumors that are positive for the TP53 R175H mutation
Principal Investigator: Rishi Surana, MD, PhD - Trial 23-158: A first in human dose escalation and cohort expansion study of DLL3-directed chimeric antigen receptor T-cells in subjects with extensive stage small cell lung cancer
Principal Investigator: Jacob Sands, MD - Trial 22-395: A phase 1 multicenter study evaluating the safety and tolerability of GCC19CART in patients with relapsed or refractory metastatic colorectal cancer (CARAPIA-1)
Principal Investigator: Benjamin Schlechter, MD
For more information, contact the relevant solid tumor treatment center.
Cell Manipulation Core Facility
For some cellular therapy products – especially in early phase clinical trials – our on-site Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) performs the primary cell manufacturing of genetically engineered products. For other cellular therapy products, cells are primarily manufactured at an outside commercial facility and the CMCF oversees the process of collecting the cells, shipment to the offsite commercial facility, return of the processed cells, and release for patient treatment.