A Phase 1 Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma

Verified

Overview

This is an investigational study of CAR2 Anti-CD38 A2 CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma. The treatment uses your own T cells to try to kill your cancerous multiple myeloma cells. T cells fight infections and can also kill cancer cells in some cases. In this study, some of your T cells will be removed from your blood by a process called leukapheresis, changed in a laboratory, and then given back to you by intravenous (IV) infusion. While your T cells are in the laboratory, new genetic material will be put into your T cells. If your genetically changed T cells recognize and attach to multiple myeloma cells, the T cells may have the ability to become activated and kill the multiple myeloma cells.

The aim of this study is to find out:

  • The side effects of study therapy and if there are any side effects which prevent further use of study therapy in humans,
  • If there is any response of your multiple myeloma to treatment with study therapy,
  • How your body reacts to study therapy and how it moves in your body. For this purpose, the level of study therapy will be measured in your blood at specific intervals after you are given study therapy (this is called pharmacokinetics).

If you meet all the criteria for being in the study, you will be entered into the study. The study is divided into the following 3 Periods: Screening, Treatment, and Observation.

Screening: The Screening Period is scheduled to take place within up to 43 days prior to receiving the study therapy and will includes the T cell collection visit. If the tests performed during the Screening Period show that you can take part in this study and your T cells grow in the laboratory so that there is an adequate number of cells available to give you an appropriate dose of study therapy, you will receive the dose of study therapy in 3 divided intravenous infusions.

Treatment: On Day 1 of the Treatment Period you will receive 10% of the dose, on Day 2 you will receive 30% of the dose, and on Day 3 you will receive 60% of the dose of study therapy. Each intravenous infusion will occur over 15 to 60 minutes. You may receive pre-medications such as Tylenol and Benadryl to help prevent a reaction to the infusion. After receiving the study therapy, you will be required to stay near to the hospital for the duration of the Treatment Period (Days 1 to 28 of the Treatment Period) to ensure rapid identification and rapid treatment of any side effects that you may experience that occur following the infusion of study therapy. You will be required to return for visits throughout the rest of the 28 day Treatment Period to be followed for safety and to perform further tests and procedures.

Observation: You will also be required to return for additional safety follow-up visits and procedures every 28 days for 5 months following the completion of the Treatment Period.

Long Term Follow-up: You will be asked to enroll into a long-term safety observation study at the End of Study visit or at your last study visit if you discontinue the study prior to the end of the Observation Period. All patients who have received modified T cell therapy regardless of the dose received will be contacted at least annually for follow-up. This follow-up visit may be by a clinic visit or by a telephone call. You will be asked about your general health and your multiple myeloma. The visit schedule for this long-term safety observation study will be every 2 months for 2 visits after the End of Study visit, then every 6 months up to year 5, and then yearly up to year 15.

SparkCures ID 944
Trial Phase Phase 1
Enrollment 72 Patients
Treatments
Trial Sponsors
  • Sorrento Therapeutics, Inc.
NCT Identifier

NCT03464916

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

  • Are at least 18 years old
  • Have Relapsed or refractory multiple myeloma
    • First Population: prior lines of therapy must have included at least lenalidomide (Revlimid®), pomalidomide (Pomalyst®), bortezomib (Velcade®), carfilzomib (Kyprolis®), and daratumumab (Darzalex®)
    • Second Population: patients who are relapsed or refractory within one year after receiving a stem cell transplant (in first or second line)
  • Must have evaluable disease
  • Must have a life expectancy of at least 12 weeks
  • Have not received anticancer therapy or investigational drug within 28 days of first dose
  • Have not received any approved anticancer chemotherapy within 21 days of first dose (exception cyclophosphamide as NMA conditioning)
  • Have not received allogenic hematopoietic stem cell transplantation (HSCT) within 6 months, does not have active graft-versus-host disease (GVHD) following transplant, or has not received immunosuppressive therapy following a transplant
  • Have not received CAR-T, CAR-T cell line, CAR-NK, CAR-pNK, CAR-NK cell line therapies, or any non-approved anti-CD38 constructs.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • The patient must either have relapsed refractory multiple myeloma (RRMM) after receiving prior lines of anti-myeloma treatments that included at least lenalidomide (Revlimid®), pomalidomide (Pomalyst®), bortezomib (Velcade®), carfilzomib (Kyprolis®), and daratumumab (Darzalex®) (refractory MM is defined as the development of disease progression during therapy with an anti-myeloma regimen or within 60 days of the last dose of an anti-myeloma regimen or the achievement of less than a partial response (PR) after greater than or equal to 2 cycles; for relapsing patients the duration from the last dose of the last prior treatment regimen to relapse must be less than or equal to 12 months); OR have multiple myeloma that is refractory to or has relapsed within 1 year of receiving high-dose therapy [HDT]/autologous stem cell transplantation [ASCT] in first- or second-line (refractory is defined as the achievement of less than a PR at the Day 90 to 100 post-ASCT response assessment)
  • Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal; OR greater than or equal to 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
  • Must have a life expectancy of at least 12 weeks
  • Subjects should be willing and able to comply with the study schedule and protocols
  • Females of childbearing potential must have 2 negative pregnancy tests, agree to ongoing pregnancy testing during the study, and sexually active female and male subjects must be willing to use an effective method to avoid pregnancies.

Exclusion Criteria:

  • Subjects who received anticancer therapy or investigational drug within 28 days of first dose
  • Subjects who received any approved anticancer chemotherapy within 21 days of first dose (exception cyclophosphamide as NMA conditioning)
  • Subjects with unresolved toxicity greater than Grade 2 from previous therapies
  • Have myeloma involvement of central nervous system (CNS) or a history of brain metastasis or spinal cord compression
  • Subjects with an ECOG performance status greater than or equal to 3
  • Has received allogenic hematopoietic stem cell transplantation (HSCT) within 6 months, have active graft-versus-host disease (GVHD) following transplant, or receiving immunosuppressive therapy following a transplant
  • Has received any CAR cell line therapies
  • Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts, at screening unless resulting from underlying RRMM.
  • Has any clinically significant elevated baseline lab results for serum creatinine, AST, and total bilirubin (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome) at screening regardless of causality.
  • Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
  • Female subjects who are pregnant or breastfeeding
  • Active bacterial, viral or fungal infections
  • Has active plasma cell leukemia
  • Has medical condition, abnormality, or psychiatric illness that would prevent study participation
  • Left ventricular ejection fraction (LVEF) less than 40%

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Mayo Clinic (Jacksonville)
Mayo Clinic (Jacksonville)

Jacksonville, FL

Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

Florida
Mayo Clinic (Jacksonville)
Mayo Clinic (Jacksonville)

Jacksonville, FL

Minnesota
Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

New York
Mount Sinai Hospital - Tisch Cancer Institute
Pennsylvania
Abramson Cancer Center - University of Pennsylvania

Resources

Patient Friendly Brochure

Download a patient-friendly brochure to learn more about this clinical trial and the best way to connect with the Roger Williams Medical Center.

SparkCures Verified

SparkCures is working closely with Sorrento Therapeutics, Inc. to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors