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ALLO-715 CAR T Cells for Multiple Myeloma (UNIVERSAL Trial)
UNIVERSAL Trial Summary
This trial is testing a new cancer treatment for adults with multiple myeloma who have relapsed or are resistant to other treatments.
UNIVERSAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowUNIVERSAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.UNIVERSAL Trial Design
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Who is running the clinical trial?
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- You do not have antibodies against the donor's cells.I do not have conditions that affect how my body absorbs medication.I have not had treatments like anti-BCMA, gene therapy, or T cell therapy.My blood, kidney, liver, lung, and heart functions are all within normal ranges.My cancer has affected or previously affected my brain or spinal cord.My multiple myeloma has returned or didn't respond to treatment, and tests show it's still present.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of HIV or hepatitis B or C.I have or had a thyroid disorder.I haven't taken strong/moderate CYP3A4 inhibitors or inducers in the last 14 days.I have had 3 or more treatments for my multiple myeloma, including specific types but my condition did not improve with the last treatment.I have had a stem cell transplant using my own cells within the last 6 weeks or received a transplant from a donor.I cannot swallow pills.I am not taking any medications that affect my heart's rhythm.I have a serious brain or nerve condition.
- Group 1: ALLO-647, ALLO-715, Nirogacestat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the geographic distribution of this research endeavor?
"Patients for this medical trial are currently being recruited at Stanford Cancer Institute (California), Medical College of Wisconsin (Wisconsin) and Banner MD Anderson Cancer Center (Arizona). Additionally, there are 12 other enrolment sites across the United States."
Are there any available slots to join this medical experiment?
"Absolutely. Clinicaltrials.gov has updated that the trial, which was first unveiled on September 23rd 2019, is actively searching for participants. 132 individuals have to be recruited from 12 distinct locations."
What impact is this experiment aiming to have in the long run?
"Over a 4-week period, the primary outcome of this trial will be to evaluate the safety and tolerability when nirogacestat is administered alongside ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647. Secondary objectives include tracking immune cells such as T cell subsets, B lymphocytes, and NK cells; measuring anti-BCMA CAR T levels; and determining anti-tumor activity through minimal residual disease detection."
What ailments can be treated with the help of ALLO-715?
"ALLO-715 has been proven to be effective in treating multiple sclerosis, acute leukemia, myelocytic disorders, and retinoblastoma."
Has the federal regulator given ALLO-715 its stamp of approval?
"The safety of ALLO-715 was assessed to be a 1, as the trial is in its initial stages with little evidence regarding efficacy and safety."
How many individuals have been registered for this medical experiment?
"To meet protocol requirements, 132 individuals that match the given inclusion criteria must join this medical research. Prospective participants can access study sites at Stanford Cancer Institute in Palo Alto and Medical College of Wisconsin in Milwaukee."
Have any other research endeavours studied the effects of ALLO-715?
"Currently, 896 trials are underway for ALLO-715 with 162 of those in Phase 3. Philadelphia is the primary location where these studies are conducted; however, 28698 other sites have been approved to take part as well."
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