Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

  • End date
    Nov 28, 2024
  • participants needed
  • sponsor
    Allogene Therapeutics
Updated on 28 January 2021


The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.

Condition Relapsed Refractory Multiple Myeloma
Treatment cyclophosphamide, Fludarabine, ALLO-647, ALLO-715, Nirogacestat
Clinical Study IdentifierNCT04093596
SponsorAllogene Therapeutics
Last Modified on28 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Relapsed Refractory Multiple Myeloma?
Do you have any of these conditions: Do you have Relapsed Refractory Multiple Myeloma??
Do you have any of these conditions: Do you have Relapsed Refractory Multiple Myeloma??
Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain [FLC]) per International Myeloma Working Group (IMWG) criteria
At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and refractory to the last treatment line
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Absence of donor (product)-specific anti-HLA antibodies
Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria

Current or history of Central Nervous System (CNS) involvement of myeloma or plasma cell leukemia
Clinically significant CNS disorder
Current or history of thyroid disorder
Autologous stem cell transplant within the last 6 weeks, or any allogeneic stem cell transplant
Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modified cell therapy, or adoptive T cell therapy
History of HIV infection or acute or chronic active hepatitis B or C infection
Patients unwilling to participate in an extended safety monitoring period
Additional Exclusion Criteria for Nirogacestat plus ALLO-715 Cohorts
Inability to swallow tablets
Subject has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 days before starting nirogacestat
Use of concomitant medications that are known to prolong the QT/QTcF interval
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note