Trial · NCT04093596

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

NCT04093596, Phase 1, Completed, Allogene Therapeutics

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL). Trials, record NCT04093596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04093596

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
NCT number: NCT04093596
Status: Completed
Phases: Phase 1
Enrollment: 73 participants, actual
Lead sponsor: Allogene Therapeutics
Conditions: Relapsed/Refractory Multiple Myeloma
Interventions: ALLO-715, ALLO-647, Fludarabine, Cyclophosphamide, Nirogacestat
First posted: 2019-09-18
Last updated: 2026-05-13

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715	28 Days	Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Primary	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.	33 days	The proportion of subjects in a dose cohort with DLTs of ALLO-647
Primary	To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.	28 days	Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Secondary	Cellular kinetics of ALLO-715	up to 60 months	Levels of anti-BCMA CAR T cells in blood
Secondary	antitumor activity of ALLO-715 in combination with nirogacestat	up to 60 months	overall -response rate (ORR)
Secondary	Cellular kinetics of ALLO-715 in combination with nirogacestat	up to 60 months	Levels of anti-BCMA CAR T cells in blood
Secondary	Pharmacokinetics of ALLO-647	up to 60 months	Serum concentration levels of ALLO-647
Secondary	Pharmacokinetics of nirogacestat	up to 60 months	Serum concentration levels of nirogacestat
Secondary	Incidence of immunogenicity against ALLO-715 and ALLO-647	up to 60 months	detection and levels of anti-drug antibodies
Secondary	Immune monitoring after lymphodepletion regimen	up to 60 months	Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36690811	BACKGROUND	PubMed
39584380	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04093596

GET https://conductscience.org/api/trials/v1/NCT04093596/registered

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