Clinical trial NCT04674813: A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
Official title: A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: CC-95266
Multiple Myeloma
Relapsed and/or Refractory
Lead sponsor: Juno Therapeutics, a Subsidiary of Celgene
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 180
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: The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months.
* Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including:

  * Autologous HSCT, unless the subject was ineligible
  * A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination
  * Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy.
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Known active or history of central nervous system (CNS) involvement of MM
* Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
* Active autoimmune disease requiring immunosuppressive therapy
* History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Number of participants with significant laboratory abnormalities
timeFrame: Up to 2 years after CC-95266 infusion
measure: Number of participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: Up to 2 years after CC-95266 infusion
Secondary outcomes:
measure: Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Pharmacokinetics - Time to peak (maximum) serum concentration (tmax)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Overall response rate (ORR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Complete response rate (CRR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Very good partial response (VGPR) or better
timeFrame: Up to 2 years after CC-95266 infusion
measure: Duration of response (DOR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Duration of complete response (DOCR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Time to response (TTR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Time to complete response (TTCR)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years after CC-95266 infusion
measure: Overall survival (OS)
timeFrame: Up to 2 years after CC-95266 infusion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 005
state: Alabama
city: Duarte
country: United States
facility: Local Institution - 009
state: California
city: San Francisco
country: United States
facility: Local Institution - 012
state: California
city: Denver
country: United States
facility: Local Institution - 002
state: Colorado
city: Baltimore
country: United States
facility: Local Institution - 008
state: Maryland
city: Boston
country: United States
facility: Local Institution - 010
state: Massachusetts
city: New York
country: United States
facility: Local Institution - 011
state: New York
city: Nashville
country: United States
facility: Local Institution - 001
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 006
state: Texas
city: Seattle
country: United States
facility: Local Institution - 003
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: