NCT06121843|RecruitingPhase 1FDA Drug

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company ClinicalTrials.gov

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1 other identifier

CA088-1005

Study Type

interventional

Target

147

Locations

2 countries

Sites

Timeline

RegisteredNov 2023

StartedFeb 2024

CompletionAug 2028

Brief Summary

The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

147

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline

27mo left

Started Feb 2024

Typical duration for phase_1 multiple-myeloma

Geographic Reach

2 countries

19 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

Study Progress50%

Feb 2024Aug 2028

First Submitted

Initial submission to the registry

November 2, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

November 2, 2023

Last Update Submit

February 13, 2026

Conditions

Multiple Myeloma

Keywords

BMS-986393Relapsed Multiple MyelomaRefractory Multiple MyelomaFirst-in-humanAlnuctamabMezigdomideIberdomideCC-95266GPRC5DGPRC5D CAR TCell TherapyCAR T cell therapyCombination therapyelranatamabarlocabtagene autoleucelarlo-cel

Outcome Measures

Primary Outcomes (6)

Incidence of adverse events (AEs)
Up to 2 years
Incidence of serious adverse events (SAEs)
Up to 2 years
Incidence of adverse events of special interest (AESI)
Up to 2 years
Incidence of AEs leading to discontinuation
Up to 2 years
Number of Deaths
Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Up to 2 years

Secondary Outcomes (6)

Overall response rate (ORR)
Up to 2 years
Complete response rate (CRR)
Up to 2 years
Very good partial response rate (VGPRR)
Up to 2 years
Maximum observed concentration (Cmax) of arlocabtagene autoleucel
Up to 2 years
Time of maximum observed concentration (tmax) of arlocabtagene autoleucel
Up to 2 years
+1 more secondary outcomes

Study Arms (4)

Arm A: BMS-986393 + Alnuctamab

EXPERIMENTAL

Drug: BMS-986393Drug: Alnuctamab

Arm B: BMS-986393 + Mezigdomide

EXPERIMENTAL

Drug: BMS-986393Drug: Mezigdomide

Arm C: BMS-986393 + Iberdomide

EXPERIMENTAL

Drug: BMS-986393Drug: Iberdomide

Arm D: BMS-986393 + Elranatamab

EXPERIMENTAL

Drug: BMS-986393Drug: Elranatamab