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P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma (MM)

The purpose of this study is to find out if an investigational treatment called P-BCMA-ALLO1 is safe and will help treat people with Multiple Myeloma. The study is also being done to determine what dose is safe and effective to treat Multiple Myeloma.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

In order to enter the study, you have to provide written consent to participate. Then you will undergo screening tests to determine if your cancer has the right characteristics and you are healthy enough to partake in the study. This is called a screening visit. Once you have passed the screening tests and enroll in the study, depending on which treatment you will receive, you may begin a conditioning regimen of chemotherapy or antibody therapy to prepare your body to receive the study drug. The study drug will be given to you after the conditioning chemotherapy or antibody therapy (if given) via an intravenous (IV) infusion. You will then be assessed to see the effects of the study drug treatment. Based on cohort and study arm, you may be required to be admitted to the hospital when you get the study drug and will stay in the hospital for 7 days afterward so the study doctor can watch you closely for any side effects. You will return to your study doctor for regular post-treatment follow up visits after your last study drug infusion. Follow up for this study could last up to 15 years.

Incentives

In-person visits:
Variable - based on disease and side effects
Phone or online visits:
Variable - based on worsened disease
Total length of participation:
Up to 15 years from last dose of study drug (this includes treatment and follow up)

Looking for Specific Volunteers

Able to participate:

  • You have confirmed diagnosis of Multiple Myelome that is relapsed/refractory and measurable
  • Your willing to practice birth control for duration of study
  • You're at least 90 days since autologous stem cell transplant, if performed
  • You have adequate organ function as defined by protocol criteria
  • Willing to comply with study requirements

Not eligible if:

  • You are pregnant or lactating
  • You have inadequate venous access
  • You have active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or one of the other conditions in the protocol considered for exclusion

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

24-3158

ClinicalTrials.gov

NCT04960579

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