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CAR T-cell Therapy
CAR T Cell Therapy for Non-Hodgkin's Lymphoma
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after cc-97540 infusion
Awards & highlights
Study Summary
This trial is testing a new cancer treatment called CC-97540, which is a type of CAR T cell. The trial will have two parts: in the first part, they will test different doses of CC-97540 to see what is safe and tolerable. In the second part, they will expand the trial to a larger group of people and test the recommended Phase 2 dose to see if it is effective and has any side effects.
Who is the study for?
Adults with certain types of B-cell non-Hodgkin lymphoma that have not responded to at least two previous treatments can join this trial. They must be in good health, able to follow the study plan, and willing to use contraception. People who've had CAR T-cell therapy or specific CD19-targeted therapies, recent corticosteroids or monoclonal antibodies, active autoimmune diseases, significant heart conditions, CNS disorders, uncontrolled infections or other serious medical issues cannot participate.Check my eligibility
What is being tested?
The clinical trial is testing CC-97540 CAR T cells for safety and effectiveness in treating relapsed or refractory B-cell non-Hodgkin lymphoma. The study has two parts: first finding the safest dose (Part A) and then seeing how well it works at that dose (Part B).See study design
What are the potential side effects?
Potential side effects include immune system reactions causing fever and flu-like symptoms; neurological events like confusion or tremors; low blood cell counts leading to increased infection risk; fatigue; allergic reactions during infusion; and possible organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after cc-97540 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after cc-97540 infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Secondary outcome measures
Complete Response Rate (CRR)
Duration of response (DOR)
Overall response Rate (ORR)
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CC-97540 monotherapyExperimental Treatment1 Intervention
Subjects will be assigned to receive CC-97540 followed by 3 consecutive doses of lymphodepleting chemotherapy (fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day).
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Who is running the clinical trial?
Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,374 Total Patients Enrolled
Ashley Koegel, MDStudy DirectorCelgene
1 Previous Clinical Trials
150 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,450 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had certain treatments or procedures recently.I am 18 years old or older.I have a significant brain or nerve condition.I have previously received CAR T-cell or CD19-targeted therapy.I haven't had a COVID-19 vaccine in the 2 weeks before my leukapheresis or starting LD chemotherapy.I am on medication for an autoimmune disease.My organs are functioning well.I have had heart problems in the last 6 months.My lymphoma diagnosis fits one of the specified types, not including Richter's transformation.I had COVID-19 within the specified time frame.I do not have any ongoing serious infections.I do not have active hepatitis B, C, or HIV.My cancer is only in my brain or spinal cord.I have been cancer-free from other types than my current NHL for 2 years or more.I have had a significant bleeding event in the last month.My condition did not improve after 2 treatments including an anthracycline and a CD20 antibody.I am fully active or can carry out light work.I am willing and able to have a biopsy if my tumor can be reached.I agree to use effective birth control as outlined in the study.I have good veins for blood collection procedures.
Research Study Groups:
This trial has the following groups:- Group 1: CC-97540 monotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites have been selected for the implementation of this research project?
"At this time, the trial is welcoming participants from 34 clinics situated in various cities across America. Examples include Birmingham, Omaha and New york. To minimise travel requirements for potential patients, it's recommended that they select a location nearby them."
Answered by AI
Is the recruitment phase of this experiment still open?
"Data hosted on clinicaltrials.gov affirms that this medical experiment is not presently involving any patients, as the last update to its post was made on October 28th 2022. Despite not being able to participate in this trial, there are 1832 other studies open for enrollment at present time."
Answered by AI
Has CC-97540 achieved authorization from the FDA?
"CC-97540's safety rating is a 1 due to its preliminary stage, as it has only been studied minimally in terms of both efficacy and safety."
Answered by AI
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