Relapsed/Refractory Multiple MyelomaPhase 1UNIVERSALNCT04093596
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
A Phase 1 study testing ALLO-715, ALLO-647 and Fludarabine in people with Relapsed/Refractory Multiple Myeloma, run by Allogene Therapeutics at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- ALLO-715, ALLO-647 and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Sep 2019to 27 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. David's South Austin Medical Center
Austin, Texas, 78704
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Sarah Cannon/Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford Cancer Institute
Palo Alto, California, 94305
Mayo Clinic
Rochester, Minnesota, 55905
Texas Transplant Institute
San Antonio, Texas, 78229
About this study
Official title: A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma
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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- ALLO-715, ALLO-647, Fludarabine, Cyclophosphamide, Nirogacestat
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-715Genetic
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647Biological
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
FludarabineDrug
Chemotherapy for lymphodepletion
CyclophosphamideDrug
Chemotherapy for lymphodepletion
NirogacestatDrug
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
| Study group | Role | What they receive |
|---|---|---|
| ALLO-647, ALLO-715, Nirogacestat | Experimental | Not described Receives: Genetic: ALLO-715; Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nirogacestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Measured: 28 Days
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.
The proportion of subjects in a dose cohort with DLTs of ALLO-647
Measured: 33 days
To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Measured: 28 days
Secondary outcomes (12)
Cellular kinetics of ALLO-715
Levels of anti-BCMA CAR T cells in blood
Measured: up to 60 months
antitumor activity of ALLO-715 in combination with nirogacestat
overall -response rate (ORR)
Measured: up to 60 months
Cellular kinetics of ALLO-715 in combination with nirogacestat
Levels of anti-BCMA CAR T cells in blood
Measured: up to 60 months
Pharmacokinetics of ALLO-647
Serum concentration levels of ALLO-647
Measured: up to 60 months
Pharmacokinetics of nirogacestat
Serum concentration levels of nirogacestat
Measured: up to 60 months
Incidence of immunogenicity against ALLO-715 and ALLO-647
detection and levels of anti-drug antibodies
Measured: up to 60 months
Immune monitoring after lymphodepletion regimen
Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Measured: up to 60 months
Anti-tumor activity of ALLO-715
overall response rate
Measured: up to 60 months
Anti-tumor activity of ALLO-715
duration of response
Measured: up to 60 months
Anti-tumor activity of ALLO-715
overall survival
Measured: up to 60 months
Anti-tumor activity of ALLO-715
minimal residual disease
Measured: up to 60 months
To evaluate the expression of BCMA in bone marrow plasma cells with and without nirogacestat
Overall response rate of ALLO-715 with and without Nirogacestat
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start23 Sep 2019
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allogene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093596
- Sponsor's protocol ID
- ALLO-715-101
- Acronym
- UNIVERSAL
- Status last verified
- May 2026
- First submitted
- 16 Sep 2019
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mailankody S, Matous JV, Chhabra S, Liedtke M, Sidana S, Oluwole OO, Malik S, Nath R, Anwer F, Cruz JC, Htut M, Karski EE, Lovelace W, Dillon M, Butz E, Ying W, Balakumaran A, Kumar SK. Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results. Nat Med. 2023 Feb;29(2):422-429. doi: 10.1038/s41591-022-02182-7. Epub 2023 Jan 23.
PubMed 36690811Abba Moussa D, Vazquez M, Chable-Bessia C, Roux-Portalez V, Tamagnini E, Pedotti M, Simonelli L, Ngo G, Souchard M, Lyonnais S, Chentouf M, Gros N, Marsile-Medun S, Dinter H, Pugniere M, Martineau P, Varani L, Juan M, Calderon H, Naranjo-Gomez M, Pelegrin M. Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches. Emerg Microbes Infect. 2025 Dec;14(1):2432345. doi: 10.1080/22221751.2024.2432345. Epub 2024 Dec 9.
PubMed 39584380
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04093596
- Acronym / sponsor ID
- UNIVERSAL / ALLO-715-101
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Allogene TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLO-647, ALLO-715, Nirogacestat | Experimental | Genetic: ALLO-715, Biological: ALLO-647, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Nirogacestat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLO-715ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA | Genetic | ALLO-647, ALLO-715, Nirogacestat |
| ALLO-647ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen | Biological | ALLO-647, ALLO-715, Nirogacestat |
| FludarabineChemotherapy for lymphodepletion | Drug | ALLO-647, ALLO-715, Nirogacestat |
| CyclophosphamideChemotherapy for lymphodepletion | Drug | ALLO-647, ALLO-715, Nirogacestat |
| Nirogacestata small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells. | Drug | ALLO-647, ALLO-715, Nirogacestat |
Primary outcome
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
Time frame: 28 Days
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion 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.
Time frame: 33 days
The proportion of subjects in a dose cohort with DLTs 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.
Time frame: 28 days
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
12 secondary outcomes
Cellular kinetics of ALLO-715
Time frame: up to 60 months
antitumor activity of ALLO-715 in combination with nirogacestat
Time frame: up to 60 months
Cellular kinetics of ALLO-715 in combination with nirogacestat
Time frame: up to 60 months
Pharmacokinetics of ALLO-647
Time frame: up to 60 months
Pharmacokinetics of nirogacestat
Time frame: up to 60 months
Incidence of immunogenicity against ALLO-715 and ALLO-647
Time frame: up to 60 months
Immune monitoring after lymphodepletion regimen
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
Time frame: up to 60 months
To evaluate the expression of BCMA in bone marrow plasma cells with and without nirogacestat
Time frame: up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 36690811Mailankody S, Matous JV, Chhabra S, Liedtke M, Sidana S, Oluwole OO, Malik S, Nath R, Anwer F, Cruz JC, Htut M, Karski EE, Lovelace W, Dillon M, Butz E, Ying W, Balakumaran A, Kumar SK. Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results. Nat Med. 2023 Feb;29(2):422-429. doi: 10.1038/s41591-022-02182-7. Epub 2023 Jan 23.
- Derived from this study: PubMed 39584380Abba Moussa D, Vazquez M, Chable-Bessia C, Roux-Portalez V, Tamagnini E, Pedotti M, Simonelli L, Ngo G, Souchard M, Lyonnais S, Chentouf M, Gros N, Marsile-Medun S, Dinter H, Pugniere M, Martineau P, Varani L, Juan M, Calderon H, Naranjo-Gomez M, Pelegrin M. Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches. Emerg Microbes Infect. 2025 Dec;14(1):2432345. doi: 10.1080/22221751.2024.2432345. Epub 2024 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALLO-715, ALLO-647 and Fludarabine in people with Relapsed/Refractory Multiple Myeloma, run by Allogene Therapeutics at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715 (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093596, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.