Clinical trial NCT03486067: Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
Official title: A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
BCMA X CD3 T Cell
Antibody
CC-93269
Relapsed and Refractory
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Detailed description: The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Eligibility criteria: Inclusion Criteria:

* History of multiple myeloma with relapsed and refractory disease
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have measurable disease as determined by the central laboratory

Exclusion Criteria:

* Symptomatic central nervous system involvement of multiple myeloma
* Prior autologous stem cell transplant ≤ 3 months prior
* Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
* History of concurrent second cancers requiring active, ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 63 months
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 60 months
measure: Non-Tolerated Dose (NTD)
timeFrame: Up to 60 months
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 60 months
measure: Time to Response
timeFrame: Up to 60 months
measure: Duration of Response
timeFrame: Up to 60 months
measure: Progression Free Survival
timeFrame: Up to 60 months
measure: Overall Survival
timeFrame: Up to 60 months
measure: Pharmacokinetics - Cmax
timeFrame: Up to 60 months
measure: Pharmacokinetics - Cmin
timeFrame: Up to 60 months
measure: Pharmacokinetics - AUC
timeFrame: Up to 60 months
measure: Pharmacokinetics - tmax
timeFrame: Up to 60 months
measure: Pharmacokinetics - t1/2
timeFrame: Up to 60 months
measure: Pharmacokinetics - CL
timeFrame: Up to 60 months
measure: Pharmacokinetics - Vss
timeFrame: Up to 60 months
measure: Pharmacokinetics - accumulation index of alnuctamab
timeFrame: Up to 60 months
measure: Presence and frequency of anti-drug antibodies (ADA)
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 105
state: Alabama
city: San Francisco
country: United States
facility: Local Institution - 103
state: California
city: New Haven
country: United States
facility: Local Institution - 107
state: Connecticut
city: Atlanta
country: United States
facility: Local Institution - 106
state: Georgia
city: Boston
country: United States
facility: Local Institution - 109
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 111
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Mount Sinai West
state: New York
city: Seattle
country: United States
facility: Local Institution - 101
state: Washington
city: Erlangen
country: Germany
facility: Local Institution - 305
city: Hamburg
country: Germany
facility: Local Institution - 303
city: Heidelberg
country: Germany
facility: Local Institution - 302
city: München
country: Germany
facility: Local Institution - 306
city: Tuebingen
country: Germany
facility: Local Institution - 304
city: Bergamo
country: Italy
facility: Local Institution - 402
city: Meldola
country: Italy
facility: Local Institution - 403
city: Milan
country: Italy
facility: Local Institution - 401
city: Nagoya-shi
country: Japan
facility: Local Institution - 602
state: Aichi
city: Shibuya-ku
country: Japan
facility: Local Institution - 603
state: Tokyo
city: Kamakura
country: Japan
facility: Local Institution - 605
city: Kashiwa
country: Japan
facility: Local Institution - 604
city: Kyoto
country: Japan
facility: Local Institution - 601
city: Barcelona
country: Spain
facility: Local Institution - 206
city: Barcelona
country: Spain
facility: Local Institution - 208
city: Madrid
country: Spain
facility: Local Institution - 205
city: Pamplona
country: Spain
facility: Local Institution - 201
city: Salamanca
country: Spain
facility: Local Institution - 203
city: Santander
country: Spain
facility: Local Institution - 204
city: Valencia
country: Spain
facility: Local Institution - 207
city: Valencia
country: Spain
facility: Local Institution - 202
city: Gothenborg
country: Sweden
facility: Local Institution - 504
city: Lund
country: Sweden
facility: Local Institution - 502
city: Stockholm
country: Sweden
facility: Local Institution - 501
city: Uppsala
country: Sweden
facility: Local Institution - 505
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: