A Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04674813 Recruiting December 19, 2020 September 23, 2021

study description
Brief Summary

This is a Phase 1, multicenter, open label, study of CC-95266 in subjects with relapsed and/or refractory multiple myeloma. The study will consist of two parts: dose escalation (Part A) and dose expansion (Part B). The dose escalation (Part A) of the study will evaluate the safety and tolerability of increasing doses of CC-95266 in a single administration to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of CC-95266 at the RP2D.

Condition or Disease: Multiple Myeloma
Intervention/treatment: Drug: CC-95266
Drug: Fludarabine
Drug: Cyclophosphamide
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 77 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date: February 2021
Estimated Primary Completion Date: June 2025
Estimated Study Completion Date: June 2025

Arms and interventions
Arm Intervention/treatment
Experimental: Administration of CC-95266
Subjects will receive CC-95266 after completion of lymphodepleting (LD) chemotherapy (fludarabine and cyclophosphamide)
Drug: CC-95266
IV

Drug: Fludarabine
IV

Drug: Cyclophosphamide
IV
outcome measures
Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
2. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years after CC-95266 infusion ]
MTD is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%
3. Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years after CC-95266 infusion ]
RP2D is defined as the dose recommended for further investigation in a Phase 2 study
Secondary Outcome Measures: 1. Pharmacokinetics - Cmax [ Time Frame: Up to 2 years after CC-95266 infusion ]
Cmax is defined as maximum plasma concentration of drug
2. Pharmacokinetics - tmax [ Time Frame: Up to 2 years after CC-95266 infusion ]
tmax is defined as time to peak (maximum) serum concentration
3. Pharmacokinetics - AUC(1-29) [ Time Frame: Up to 2 years after CC-95266 infusion ]
AUC(1-29) is defined as area under the curve for days 1-29 after CC-95266 infusion
4. Overall response rate (ORR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
ORR is defined as proportion of subjects achieving sCR, CR, VGPR, or PR
5. Complete response rate (CRR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
CRR is defined as proportion of subjects with sCR or CR
6. Duration of response (DOR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
DOR is defined as the time from first response (sCR, CR, VGPR, or PR) to PD or death
7. Duration of complete response (DOCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
DOCR is defined as a best overall response of sCR or CR, time from first response (sCR, CR, VGPR, or PR) to the first documentation of PD or death
8. Time to response (TTR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
TTR is defined as time from CC-95266 infusion to the first documentation of response (sCR, CR, VGPR, or PR)
9. Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
TTCR is defined as time from CC-95266 infusion to the first documentation of sCR or CR
10. Progression-free survival (PFS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
PFS is defined as time from CC-95266 infusion to the first documentation of PD, or death from any cause, whichever occurs first
11. Overall survival (OS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
OS is defined as time from CC-95266 infusion to death

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Age ≥ 18 years. Signed written informed consent prior to any study procedure. Subject has a diagnosis of multiple myeloma with relapsed and/or refractory disease. Subjects must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for subjects with cellular therapy (eg, CAR T-cell therapy) as their last treatment, who may enroll beyond 12 months.

Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without HSCT and with or without maintenance therapy is considered one regimen), including:

Autologous stem cell transplant A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination Anti-CD38 (eg, daratumumab), either alone or combination 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 Uncontrolled or active infection 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, organic brain syndrome, or psychosis


Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, Alabama University of Alabama Birmingham Birmingham
United States, California City of Hope Duarte
United States, Colorado Colorado Blood Cancer Institute Denver
United States, Maryland University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore
United States, Massachusetts Dana Farber Cancer Institute Boston
United States, New York Icahn School of Medicine at Mount Sinai Medical Center New York
United States, Tennessee Sarah Cannon Research Institute Center for Blood Cancers Nashville
United States, Texas Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center Dallas
United States, Washington Swedish Cancer Institute Seattle
Sponsors and Collaborators
Juno Therapeutics, a Subsidiary of Celgene
Investigator
Study Director : Allison Kaeding, MD Bristol-Myers Squibb
More Information
Responsible Party : Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier : NCT04674813     
Other Study ID Numbers : CC-95266-MM-001, U1111-1260-4921
First Posted : December 19, 2020
Last Update Posted : September 23, 2021
Last Verified : September 2021
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juno Therapeutics, a Subsidiary of Celgene: CC-95266
Multiple Myeloma
Relapsed and/or Refractory
Additional relevant MeSH terms :
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases