The Cellular Immune Tolerance (CIT) Program is a collaboration between multiple departments at Stanford Medicine dedicated to bringing cutting-edge cellular immune therapy to treat patients with autoimmunity or undergoing transplantation. Cellular therapy therapies offer the promise to more significantly and completely treat patients than other modalities.

The program focus is on human translational and clinical trial studies and supporting investigators across Stanford Medicine.

Stanford CIT Program Objectives

    1. Champion participant safety and access to clinical trials
    2. Be the vanguard in cutting-edge cell therapies and scientific studies
    3. Support inter- and intra-departmental team science at the Stanford University School of Medicine
    4. Build industry collaborations to increase cell therapeutic trial engagement
    5. Convert our knowledge from clinical trials to the new standard-of-care

The Stanford CIT has an unparalleled infrastructure to develop and operationalize cell therapy trials. We spearhead a team science approach to our research, bringing together clinical, scientific, regulatory, and operational experts from within the Stanford Department of Medicine. 

Stanford CIT interventions include Bone Marrow Transplantation, Mixed Chimerism, Regulatory T cells, and CAR-T cell therapies. The Stanford CIT’s clinical trial portfolio is diverse and interdepartmental. Stanford CIT’s clinical trial portfolio includes both investigator-initiated trials at Stanford Medicine, as well as sponsor-initiated studies.

    • Rheumatology
    • Transplantation
    • Blood and Marrow Transplantation
    • Dermatology
    • Nephrology
    • Hematology
    • Neuroimmunology
    • Type 1 diabetes

CLINICAL TRIALS PORTFOLIO

A major goal of Stanford CIT is to spearhead innovations in immunomodulatory and cell therapies to improve patient quality of life and better induce immune tolerance among organ transplant recipients. Based on the legacy of Dr. Sam Strober, Stanford CIT is a global leader in kidney tolerance induction and aims to reduce or eliminate the need for lifelong immunosuppression using combined kidney and hematopoietic stem cell transplantation.

ENROLLING NOW

Kidney Tolerance Induction – Living Donor (Busque)

Multiple Low Dose Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34 and T-cell Transfusion in Living Donor Kidney Transplantation (CIRM), IRB no. 40442
NCT03292445

Multiple-Low Dose Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T Cell Transfusion in Living Mismatch Donor Kidney Transplantation, IRB no. 54348
NCT01165762

Kidney Tolerance Induction – Treg

A Phase I Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation. IRB no. 50540
NCT03943238

Kidney Tolerance Induction – Deceased Donor

Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment, IRB no. 57511
NCT04571203

Kidney Tolerance Induction – The Second Chance Study

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation. The Second Chance Study. IRB no. 46787
NCT03591302

Islet Transplantation

Clinical Islet Transplantation with Apheresis, Isolation and Reintroduction of Recipient Regulatory T cells or Administration of Deceased Donor Vertebral Bone Marrow in Type 1 Diabetes, IRB no. 58350

Multiple Sclerosis

A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis, IRB no. 70408

Lupus Nephritis

A Phase 1, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis, IRB no. 70818

Myasthenia Gravis

A Phase 2, Open-Label, Multicentre Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6), IRB no. pending

Dermatomyositis – B-cell Depleting Chimeric Antigen Receptor T Cell Therapy

A Phase 1B, Open-Label, Single Center Study of KYV 101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Adult Patients with treatment refractory Dermatomyositis, IRB no. 73036

Chimeric Antigen Receptor Regulatory T Cell Therapy – Rheumatoid Arthritis

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis, IRB no. 71062

Scleroderma

A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Systemic Sclerosis (KYSA-5), IRB no. 73036
NCT no. pending

RECRUITMENT CONTACTS

Please inquire with our recruitment contacts, found on our website within the menu bar, for additional information. We will make every effort to update this website when the studies are ready to accept new participants.

Renata Gilfanova, MD
Clinical Trials Portfolio Manager
rgilfan@stanford.edu

Lori Panu, MPH
Clinical Research Program Manager
Stanford Center for Clinical Research
lpanu@stanford.edu