Purpose of this Study
We are doing this study to find out if an experimental therapy called CB-011 (the study drug) is a safe and effective option for people who have relapsed or refractory multiple myeloma.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with multiple myeloma that has relapsed or has not responded to standard therapies</li>
<li>Have received at least 3 prior lines of treatment that include the use of a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of these lines of therapy (drugs could be taken alone or in combination with each other)</li>
<li>Have undergone at least 2 complete cycles of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy or the treatment could not be tolerated</li>
<li>Have never received treatment with CAR-T cell therapy</li></ul>
For more information about who can join this study, please contact the study team at 919-668-2556.
<li>Are diagnosed with multiple myeloma that has relapsed or has not responded to standard therapies</li>
<li>Have received at least 3 prior lines of treatment that include the use of a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of these lines of therapy (drugs could be taken alone or in combination with each other)</li>
<li>Have undergone at least 2 complete cycles of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy or the treatment could not be tolerated</li>
<li>Have never received treatment with CAR-T cell therapy</li></ul>
For more information about who can join this study, please contact the study team at 919-668-2556.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a bone marrow biopsy</li></ul>
After the screening period, this study is divided into 2 parts: Part A and Part B. You will participate in either Part A or Part B of the study, but not both parts. Whether you participate in Part A or Part B will depend on when you join the study.
In Part A, we will test different doses of the study drug to see how safe and effective they are. The primary purpose of Part A is to determine the highest dose of CB-011 that is safe in participants. Part A participants will receive only 1 dose of the study drug.
If Part A is successful, Part B will begin. In Part B, participants will receive the dose of the study drug that was found to be most safe and effective in Part A. Part B participants will also receive only a single dose.
For both parts of the study, you will undergo 3 days of lymphodepletion, which is given daily (either inpatient or outpatient) and followed by approximately 2 days of rest. After the rest period, you will receive a single infusion of the study drug in the hospital. You will need to remain in the hospital for observation and laboratory tests for 7 days after your infusion.
You will have regular check-ups with us for about a year after you get the study drug. After this year, you will enter a follow-up phase of this study where you must attend regular clinic visits and undergo medical tests and assessments about every 3 months through year 2 following your infusion. After year 2, there will be a long-term follow-up study for up to 15 years after the study drug infusion.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a bone marrow biopsy</li></ul>
After the screening period, this study is divided into 2 parts: Part A and Part B. You will participate in either Part A or Part B of the study, but not both parts. Whether you participate in Part A or Part B will depend on when you join the study.
In Part A, we will test different doses of the study drug to see how safe and effective they are. The primary purpose of Part A is to determine the highest dose of CB-011 that is safe in participants. Part A participants will receive only 1 dose of the study drug.
If Part A is successful, Part B will begin. In Part B, participants will receive the dose of the study drug that was found to be most safe and effective in Part A. Part B participants will also receive only a single dose.
For both parts of the study, you will undergo 3 days of lymphodepletion, which is given daily (either inpatient or outpatient) and followed by approximately 2 days of rest. After the rest period, you will receive a single infusion of the study drug in the hospital. You will need to remain in the hospital for observation and laboratory tests for 7 days after your infusion.
You will have regular check-ups with us for about a year after you get the study drug. After this year, you will enter a follow-up phase of this study where you must attend regular clinic visits and undergo medical tests and assessments about every 3 months through year 2 following your infusion. After year 2, there will be a long-term follow-up study for up to 15 years after the study drug infusion.
Study Details
Full Title
A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic anti-BCMA CAR-T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00112753
NCT ID
NCT05722418
Phase
I
Enrollment Status
Open to Enrollment