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CAR T-cell Therapy

ALLO-715 CAR T Cells for Multiple Myeloma (UNIVERSAL Trial)

Phase 1
Waitlist Available
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

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.

Who is the study for?
Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including specific inhibitors and antibodies, can join this trial. They must be in good physical condition with no significant CNS disorders, HIV, hepatitis B or C infections, recent stem cell transplants, or conditions affecting drug absorption.Check my eligibility
What is being tested?
The UNIVERSAL study is testing the safety and effectiveness of ALLO-715 CAR T cells alone or combined with Nirogacestat following a lymphodepletion regimen. This involves using ALLO-647 along with fludarabine and/or cyclophosphamide to prepare the body for treatment.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, blood count changes leading to increased infection risk or bleeding problems. Organ function could also be affected.

UNIVERSAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, kidney, liver, lung, and heart functions are all within normal ranges.
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My multiple myeloma has returned or didn't respond to treatment, and tests show it's still present.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have had 3 or more treatments for my multiple myeloma, including specific types but my condition did not improve with the last treatment.

UNIVERSAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
To assess the overall safety profile and tolerability of ALLO-647 in combination with Fludarabine and/or cyclophosphamide or ALLO-647 alone, prior to ALLO-715 to confirm the dose of ALLO-647.
To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.
Secondary outcome measures
Anti-tumor activity of ALLO-715
Cellular kinetics of ALLO-715
Cellular kinetics of ALLO-715 in combination with nirogacestat
+6 more

UNIVERSAL Trial Design

1Treatment groups
Experimental Treatment
Group I: ALLO-647, ALLO-715, NirogacestatExperimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Allogene TherapeuticsLead Sponsor
5 Previous Clinical Trials
560 Total Patients Enrolled
1 Trials studying Multiple Myeloma
136 Patients Enrolled for Multiple Myeloma

Media Library

ALLO-715 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04093596 — Phase 1
Multiple Myeloma Research Study Groups: ALLO-647, ALLO-715, Nirogacestat
Multiple Myeloma Clinical Trial 2023: ALLO-715 Highlights & Side Effects. Trial Name: NCT04093596 — Phase 1
ALLO-715 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093596 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~56 spots leftby Sep 2027