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CAR T-cell Therapy
CC-95266 for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Juno Therapeutics, a Subsidiary of Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after cc-95266 infusion
Awards & highlights
Study Summary
This trial is testing a new drug for people with multiple myeloma who haven't responded to other treatments. They want to see if it's safe and if it works.
Who is the study for?
This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment. They must have had at least three prior treatments (or one to three for a specific group) and show signs of disease progression. Good physical health and organ function are required, but those with central nervous system involvement, certain medical histories, or active autoimmune diseases can't join.Check my eligibility
What is being tested?
The study tests the safety and initial effectiveness of CC-95266 in patients whose multiple myeloma has relapsed or is resistant to treatment. It also involves other drugs like Cyclophosphamide, Fludarabine, and Bendamustine as part of the therapy regimen.See study design
What are the potential side effects?
Potential side effects may include nausea, hair loss from Cyclophosphamide; immune system suppression from Fludarabine; skin reactions and possible kidney damage from Bendamustine; plus any unknown risks associated with the new drug CC-95266.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after cc-95266 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after cc-95266 infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of participants with Adverse Events (AEs)
Number of participants with Dose Limiting Toxicities (DLTs)
+2 moreSecondary outcome measures
Complete response rate (CRR)
Duration of complete response (DOCR)
Duration of response (DOR)
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Administration of CC-95266Experimental Treatment4 Interventions
Subjects will receive CC-95266 after completion of lymphodepleting (LD) chemotherapy (fludarabine and cyclophosphamide)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1080
Bendamustine
2015
Completed Phase 3
~2950
Find a Location
Who is running the clinical trial?
Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,214 Total Patients Enrolled
3 Trials studying Multiple Myeloma
319 Patients Enrolled for Multiple Myeloma
Allison Kaeding, MDStudy DirectorBristol-Myers Squibb
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,519 Previous Clinical Trials
3,372,009 Total Patients Enrolled
74 Trials studying Multiple Myeloma
25,890 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant brain or nerve condition.I am fully active or can carry out light work.My multiple myeloma has worsened or not responded to treatment within the last 12 months.My organs are working well.You have a disease that can be measured or seen.I am on medication to suppress my immune system due to an autoimmune disease.I am 18 years old or older.If you are in Part A, or Part B Cohort A, or Part B Cohort B, you must have had at least 3 previous treatments for myeloma. If you are in Part B Cohort C, you must have had at least 1 but not more than 3 previous myeloma treatments, including specific therapies.This criterion refers to people who currently have or have had certain medical conditions in the past.I have or had multiple myeloma affecting my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of CC-95266
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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