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New treatment option for Relapsed/Refractory Multiple Myeloma
Official title CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05722418
What this study is testing
What is CB-011?
CB-011 is an investigational medicine, being studied as a potential treatment for relapsed/refractory multiple myeloma.
Also referred to as Cyclophosphamide, Fludarabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
- Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an...
- Eastern Cooperative Oncology Group performance status grade of 0 or 1.
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
You likely can't join if
- Prior treatment with CAR-T cell therapy directed at any target.
- Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
- Allogeneic stem cell transplant within 6 months before lymphodepletion.
- Known active or prior history of CNS involvement.
- Stroke or seizure within 6 months of signing ICF.
- Seropositive for or history of human immunodeficiency virus.
See the full eligibility criteria
- Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
- Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in...
- Eastern Cooperative Oncology Group performance status grade of 0 or 1.
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
- Prior treatment with CAR-T cell therapy directed at any target.
- Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
- Allogeneic stem cell transplant within 6 months before lymphodepletion.
- Known active or prior history of CNS involvement.
- Stroke or seizure within 6 months of signing ICF.
- Seropositive for or history of human immunodeficiency virus.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
- Hepatitis B infection.
- Hepatitis C infection.
- Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Lexington, Kentucky, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Aurora, Colorado, United States; Miami, Florida, United States; Lexington, Kentucky, United States; Hackensack, New Jersey, United States; New York, New York, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.