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CAR T-cell Therapy
CAR T Therapy for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Gracell Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an ECOG performance status of 0 or 1
Received at least three prior MM treatment lines of therapy
Must not have
History of severe non-ischemic cardiomyopathy
Received an allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD), or an autologous stem cell transplant ≤12 weeks before apheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new therapy using modified immune cells to treat adults with a type of blood cancer that has returned or not responded to treatment. The therapy aims to target and kill cancer cells by recognizing specific proteins on them. This new approach enhances the patient's own immune cells to detect and eliminate cancer cells.
Who is the study for?
Adults with relapsed/refractory Multiple Myeloma who have tried at least three treatment lines including a PI, IMiD, and an antiCD38 antibody. They must have measurable disease, good bone marrow and organ function, be over 18 years old with an ECOG status of 0 or 1. Exclusions include other cancers within the last two years (except certain skin cancers), severe heart issues, CNS involvement by myeloma, specific related diseases like POEMS syndrome or AL amyloidosis.
What is being tested?
The trial is testing GC012F, a dual-targeting CAR T therapy aimed at CD19 and BCMA in patients with multiple myeloma that has come back or hasn't responded to treatment. It's an early-phase study where all participants receive the experimental therapy to evaluate its safety and effectiveness.
What are the potential side effects?
Potential side effects may include immune system reactions due to cell targeting which can affect normal cells as well as cancerous ones; symptoms could range from mild allergic responses to more serious conditions affecting blood counts or organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have undergone at least three different treatments for multiple myeloma.
Select...
I've been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
Select...
My condition is officially diagnosed as multiple myeloma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of severe heart muscle disease not caused by poor blood flow.
Select...
I had a stem cell transplant less than 6 months ago and have no GVHD.
Select...
My multiple myeloma has affected or is affecting my brain or spinal cord.
Select...
I have a specific blood cancer or related condition.
Select...
I have had serious heart rhythm problems or fainting spells not caused by dehydration.
Select...
I have severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1b Adverse Events (AEs)
Phase 1b Dose-limiting toxicities
Phase 2 Overall response rate (ORR)
Secondary study objectives
Phase 1b Pharmacokinetic - AUC
Phase 1b Pharmacokinetic - Cmax
Phase 1b Pharmacokinetic - Tmax
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: GC012FExperimental Treatment1 Intervention
GC012F will be administrated in one infusion
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments often target specific proteins or pathways critical to the survival and proliferation of myeloma cells. Proteasome inhibitors like bortezomib disrupt protein degradation, leading to cell death.
Immunomodulatory drugs such as lenalidomide enhance the immune response against myeloma cells and inhibit their growth. Monoclonal antibodies like daratumumab target specific antigens on myeloma cells, marking them for destruction by the immune system.
CAR T-cell therapies, including the CD19/BCMA dual-targeting approach in the GC012F trial, involve modifying a patient's T-cells to express receptors that specifically recognize and kill myeloma cells. These mechanisms are crucial as they offer targeted, effective strategies to combat the disease, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
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Who is running the clinical trial?
Gracell Biopharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Yingda WenStudy DirectorGracell Biopharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow and organs are functioning well.I have a history of severe heart muscle disease not caused by poor blood flow.I am fully active or restricted in physically strenuous activity but can do light work.I had a stem cell transplant less than 6 months ago and have no GVHD.Your medical records show that your disease has been getting worse according to specific criteria.My multiple myeloma has affected or is affecting my brain or spinal cord.I have a specific blood cancer or related condition.I have undergone at least three different treatments for multiple myeloma.I've been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.I have had serious heart rhythm problems or fainting spells not caused by dehydration.I have not had a heart attack or heart surgery in the last 6 months.I have no active cancer except for my multiple myeloma or a non-melanoma skin cancer that's been treated.You must have a detectable disease when you are screened for the trial.I have severe heart failure.I am 18 years old or older.My condition is officially diagnosed as multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: GC012F
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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