CAR-T Cell Therapy Program

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. CD19-Directed CAR-T Cell Therapy For The Treatment Of Relapsed/​Refractory B Cell Malignancies

   Rochester, Minn.

   The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.

   The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified T cells are called the IC19/1563 treatment. The dose of IC19/1563 will depend on when the patient is enrolled on to the study.

    

2. Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

   Rochester, Minn., Jacksonville, Fla.

   The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.

3. Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

   Jacksonville, Fla., Rochester, Minn.

   The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

4. MC230818 Understanding The Mechanisms Of Clonal And Non-clonal Cytopenia Following CAR-T Therapy

   Rochester, Minn., Jacksonville, Fla., La Crosse, Wis., Mankato, Minn., Scottsdale/Phoenix, Ariz., Eau Claire, Wis., Albert Lea, Minn.

   This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene mutations may help identify the risk of cytopenia in patients with multiple myeloma or CD19 positive LPD following CAR-T therapy.

5. Long-Term Follow-up Protocol For Participants Treated With Gene-Modified T Cells

   Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Rochester, Minn.

   This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
   
   Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

6. A Study To Evaluate The Safety And Effectiveness Of Lisocatagene Maraleucel In Patients

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.