Clinical Trial Goal
To find out if antiocabtagene autoleucel is safe and works well to treat multiple myeloma that has relapsed or is refractory, compared to standard treatment
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma that has relapsed or is refractory
- Have been treated with the following (your doctor can tell you this):
- CD38 monoclonal antibody
- Immunomodulatory drug (IMiD)
- Do not have any of the following:
- Amyloidosis
- Plasma cell leukemia
- POEMS syndrome
- Waldenstrom's macroglobulinemia
- Have not been treated with any of the following (your doctor can tell you this):
- BCMA-targeted therapy
- CAR T-cell therapy
- T-cell engager therapy
- Have not had autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
- Have not had allogeneic (cells from a donor) BMT
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Bortezomib is a small molecule inhibitor that blocks proteasome function in certain cells.
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
Carfilzomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Cyclophosphamide, fludarabine and pomalidomide are chemotherapy drugs that block the growth of cancer cells.
Daratumumab is a monoclonal antibody that targets CD38 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
Carfilzomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Cyclophosphamide, fludarabine and pomalidomide are chemotherapy drugs that block the growth of cancer cells.
Daratumumab is a monoclonal antibody that targets CD38 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Antiocabtagene autoleucel, plus cyclophosphamide plus fludarabine
- Group 2 – Bortezomib plus carfilzomib plus daratumumab plus pomalidomide
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
Group 1 Only
To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions 3 times
- Fludarabine– Given as IV infusions 3 times
Then, the CAR T cells are given to you through an IV infusion.
Group 2 Only
- Bortezomib - Given as IV infusions or as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been
- Carfilzomib - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has beenThe dose you'll get depends on when you started the trial and how safe it's been
- Daratumumab - Given as IV infusions or as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been
- Pomalidomide - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
The clinical trial doctors will watch you closely for up to 4 years. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.
The Food and Drug Administration (FDA) has not yet approved antiocabtagene autoleucel.
Watch a video about CAR T-Cell Therapy
The Food and Drug Administration (FDA) has not yet approved antiocabtagene autoleucel.
Watch a video about CAR T-Cell Therapy
Locations
Sponsors
collaborator: Arcellx, Inc., lead: Kite, A Gilead Company
