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CAR T-cell Therapy
CART-ddBCMA for Multiple Myeloma (iMMagine-1 Trial)
Phase 2
Recruiting
Research Sponsored by Kite, A Gilead Company
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 24 months
Awards & highlights
iMMagine-1 Trial Summary
This trial is testing a new cancer treatment that uses a patient's own immune cells to target and destroy cancer cells.
Who is the study for?
Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including proteasome inhibitors, IMiDs, and anti-CD38 antibodies. They must show measurable disease signs, be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and proper organ function. Participants should not be pregnant or breastfeeding and must agree to use effective birth control for a year post-treatment.Check my eligibility
What is being tested?
The trial is testing CART-ddBCMA, which is a type of CAR-T cell therapy targeting BCMA on cancer cells. It's for patients whose multiple myeloma has returned after treatment or hasn't responded to standard therapies. The study will assess the safety and effectiveness of this new intervention.See study design
What are the potential side effects?
CAR-T cell therapies like CART-ddBCMA can cause cytokine release syndrome (flu-like symptoms such as fever and fatigue), neurological effects (confusion or difficulty speaking), low blood cell counts leading to increased infection risk, bleeding issues, and potential allergic reactions.
iMMagine-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Anti-anitocabtagene-autoleucel Antibodies
Duration of Response (DoR)
Health Related Quality of Life (HRQoL)
+10 moreiMMagine-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: anitocabtagene-autoleucelExperimental Treatment1 Intervention
Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously
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Who is running the clinical trial?
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,467 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,467 Patients Enrolled for Multiple Myeloma
Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,546 Total Patients Enrolled
3 Trials studying Multiple Myeloma
98 Patients Enrolled for Multiple Myeloma
Arcellx, Inc.Industry Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Multiple Myeloma
65 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had plasma cell leukemia.My multiple myeloma has not responded to 3 types of treatments including a proteasome inhibitor, IMiD, and anti-CD38 antibody.I am 18 or older and can understand and agree to the study's details.
Research Study Groups:
This trial has the following groups:- Group 1: anitocabtagene-autoleucel
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.
What are the risks associated with CART-ddBCMA treatment?
"CART-ddBCMA falls into the category of a Phase 2 trial, which means that while there is some evidence supporting its safety, none exists for its efficacy. Therefore, it received a score of 2."
Answered by AI
Are individuals with the relevant medical condition able to enroll in this trial at this time?
"According to the latest update on clinicaltrials.gov, this study is not currently looking for new participants. This trial was first posted on July 15th, 2022 and was last updated on July 7th, 2022. 827 other trials are actively recruiting patients right now."
Answered by AI
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