Study of CD8+ anti-BCMA CAR T-cells in Patients with Multiple Myeloma

Verified

Overview

The main purpose of this study is to evaluate the safety of an investigational CAR-T cell therapy called Descartes-08. The study will also explore whether Descartes-08 provides any treatment benefit in patients with Multiple Myeloma.

If you choose to participate and qualify, Descartes-08 will be custom-made for you from your own blood cells. Descartes-08 cells are CAR-T cells, which are T-cells that have been modified to attack myeloma (tumor) cells. To modify the cells, the Sponsor inserts new instructions into the T-cells. These instructions cause the cells to produce a new piece of cellular machinery called a CAR (Chimeric Antigen Receptor). The CAR in Descartes-08 causes T-cells to kill other cells that carry a marker called BCMA. Because the BCMA marker is present on myeloma cells, it is hoped that Decartes-08 will destroy the myeloma cells without harming most other cell types. However, the BCMA marker is not unique to myeloma cells. Plasma cells, whose role is to protect you from certain kinds of infection, also produce BCMA. Descartes-08 could have an unwanted effect on these cells.

If you choose to participate and qualify for this study, T-cells will be collected from your blood with equipment called an apheresis machine. Your T-cells will be sent to a special laboratory where they will be processed into Descartes-08 cells and quality-tested. If the cells meet all quality standards, they will be sent back to your clinic. Normally, production of Descartes-08 cells will take about one to two weeks.

How will I receive Descartes-08?

The scheduled procedures for this study will occur in the outpatient clinic.

Once your Descartes-08 cells arrive at the clinic, they will be kept in the freezer. Before you can receive the Descartes-08 cells, you will receive three days of chemotherapy. This consists of two FDA-approved medicines called fludarabine and cyclophosphamide. It is hoped that the chemotherapy will improve the activity of the Descartes-08 cells.

Two days after the chemotherapy, after meeting pre-determined laboratory criteria, Descartes-08 will be infused into your bloodstream. You will receive Descartes-08 in multiple doses over a week. During that time, you will be monitored for any adverse reactions.

How long will I be in the study? How many other people will be in the study?

Your participation in this study will last about 12 months but could be shorter. About 15 people will participate. The study will be run at several study clinics.

What am I being asked to do?

The following is a visit-by-visit description of what you are expected to do.

  • Screening: This is the first scheduled visit. The purpose of this visit is to determine if you qualify for the study. You will report to the study clinic. The study doctor will review your medical history and conduct a physical exam. The study doctor will perform or review blood and urine tests, bone marrow biopsy results and imaging studies, if applicable. The study doctor may need to do (or redo) some of these tests. The Screening visit is expected to last about 1 hour. Once the visit is complete, you will receive an appointment for your next visit.
  • Apheresis day: On the day of apheresis, you will return to the clinic. Your apheresis procedure will be supervised by trained blood bank personnel. The machine will work in cycles. First, the machine will draw blood from you and collect the T cells from your blood. Second, the machine will return your red blood cells and platelets to you. The apheresis visit is expected to last about 3 hours. Once the apheresis is complete, you will receive an appointment for your next visit.
  • Pre-conditioning chemotherapy: You will return to the clinic about five days before you are scheduled to receive the Descartes-08 cells. The study doctor or staff will ask you about health and medications and perform a physical exam. The study doctor may repeat some of your blood tests, including pregnancy test if applicable. You will then receive the chemotherapy, which consists of two FDA-approved medications called fludarabine and cyclophosphamide. The drugs will be infused over a period of 2-3 hours. You will return to the clinic over the next 2 days to complete your pre-conditioning chemotherapy.
  • Descartes-08 infusion: Three days after your last dose of chemotherapy, you will return to the study clinic to start receiving the Descartes-08 cells. The study doctor or staff will ask you about health and medications and perform a physical exam.

The Descartes-08 cells that have been prepared for you will then be administered into your bloodstream (infused).

It is expected to take about 15-30 minutes to infuse the Descartes-08 cells into your bloodstream. You will have to remain in the clinic for up to 4 hours after you receive the Descartes-08 cells. During this time the clinic personnel will monitor you.

You will return to the clinic over the first week to receive repeat doses of Descartes-08.

  • 2-week follow-up: You will return to the study clinic about one week later. The study doctor or staff will ask you about health and medications and perform a physical exam. You will have approximately 6-8 tablespoons of blood drawn for laboratory tests, including research blood. The visit is expected to last about 1-2 hours.
  • 1-month follow-up: You will return to the study clinic about one week later. The study doctor or staff will ask you about health and medications and perform a physical exam. You will have a repeat bone marrow aspirate or biopsy. You may be asked to have imaging tests such as a CT scan or chest x-ray. You will have approximately 6-8 tablespoons of blood drawn for laboratory tests, including research blood. The visit is expected to last about 3-4 hours.

After this visit, the study doctor will review the results of your tests. If your Multiple Myeloma has progressed (worsened) during the trial, you will be removed from the clinical trial. Your study doctor will speak with you about your treatment options.

  • Further Follow-up: If the early response assessment shows that your disease has not progressed since your last visit, then you will be asked to come to the clinic about 3, 6, 9 and 12 months after your Descartes-08 infusions. The study doctor or staff will ask you about health and medications and perform a physical exam. You may be asked to have another bone marrow aspiration or biopsy. You will have approximately 6-8 tablespoons of blood drawn for laboratory tests, including research blood. Each visit is expected to last about 30-45 minutes.

At any of these visits, depending on the status of your Multiple Myeloma, your study doctor may continue to observe you without additional treatment, or may discuss with you other treatment options.

When is the study over?

Your participation in the study will end at the 12-month visit or earlier if you withdraw from the study or the study doctor withdraws you. The study doctor can withdraw you at any time if you fail to show up for study visits or follow study instructions, or if the study doctor thinks withdrawal is necessary for your health or safety (or if you become pregnant). Your withdrawal would not require your consent, but you would be informed of this decision and the reason.

Can I leave the study before it ends?

You are free to leave the study at any time. Withdrawal will not interfere with your future care. If you decide not to continue with the study, tell the study doctor. The study doctor may still recommend tests or a follow-up visit to monitor your health.

Will I be reimbursed for travel and accommodation?

The Sponsor is providing reimbursement for travel and accommodation. Please contact study staff for details.

SparkCures ID 943
Trial Phase Phase 1
Enrollment 15 Patients
Treatments
Trial Sponsors
  • Cartesian Therapeutics
NCT Identifier

NCT03448978

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.

  • Patients 18 years and older
  • Patients with prior CAR-T therapy and prior anti-BCMA therapy are allowed.
  • Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
  • Measurable disease defined as a serum M-protein > 0.5 mg/dL or a urine M-protein > 200mg/24 hours or biopsy-proven plasmacytoma or greater than 5% bone marrow plasma cells.
  • Adequate vital organ function as indicated by absolute neutrophil count > 1000/ mm3, platelets > 50,000/mm3, normal cardiac function, ALT/AST levels lower than or equal to 3-fold of normal, creatinine clearance greater than or equal to 30mL/min or 30mL/min/1.73m2, no active infection, and informed consent, including at least one bone marrow biopsy
  • Patients with plasma cell leukemia are not eligible
  • Patients are not eligible if they have any active and uncontrolled infection

The following criteria is provided for health care professionals.

Inclusion Criteria (condensed):

  • Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
  • Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.
  • Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each < 2.5 3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (> 60 30 mL/min), and cardiac ejection fraction (> 50 45%)

Exclusion Criteria (condensed):

  • Plasma cell leukemia
  • Pregnant or lactating
  • Active, uncontrolled infection
  • Active and severe auto-immune disease
  • Active arrhythmia, or obstructive or restrictive pulmonary disease
  • Central nervous system disease

US Trial Locations

Accepting Patients

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

Center for Cancer and Blood Disorders
Center for Cancer and Blood Disorders

Bethesda, MD

Billings Clinic Cancer Center
West Cancer Center<br />Memphis Professional Building
West Cancer Center
Memphis Professional Building

Memphis, TN

Virginia Cancer Specialists
Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

University of Oklahoma Health Sciences Center
University of Oklahoma Health Sciences Center

Oklahoma City, OK

Connecticut
Yale Cancer Center<br />Smilow Cancer Hospital at Yale-New Haven
Maryland
Center for Cancer and Blood Disorders
Center for Cancer and Blood Disorders

Bethesda, MD

Montana
Billings Clinic Cancer Center
New Jersey
John Theurer Cancer Center<br />Hackensack Meridian Health
Oklahoma
University of Oklahoma Health Sciences Center
University of Oklahoma Health Sciences Center

Oklahoma City, OK

Tennessee
West Cancer Center<br />Memphis Professional Building
West Cancer Center
Memphis Professional Building

Memphis, TN

Virginia
Virginia Cancer Specialists
Washington, D.C.

Resources

There are no resources, links or videos to display for this clinical trial.

SparkCures Verified

SparkCures is working closely with Cartesian Therapeutics 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