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CAR T-cell Therapy
CAR T-Cell Therapy for Multiple Myeloma
Phase 1
Waitlist Available
Led By Sham Mailankody, MBBS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1
At least 100 days since ASCT for patients with prior ASCT at the time of initial screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test the safety of MCARH109 at different doses to see which is safest for people and to look for any positive or negative effects of the treatment. The treatment could stop the growth of cancer, but may also cause side effects.
Who is the study for?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to treatment, including a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody. They should have had at least three prior treatments and meet specific health criteria like good organ function and blood counts.Check my eligibility
What is being tested?
The study tests different doses of MCARH109 T cells infused into patients to find the safest dose. It aims to determine the effects of this CAR T-cell therapy on stopping cancer growth while monitoring any side effects that may occur during treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, CAR T-cell therapies like MCARH109 can cause side effects such as cytokine release syndrome (flu-like symptoms), neurologic events (confusion or difficulty speaking), low blood cell counts, infection risk increase, and potential allergic reactions.
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.
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It has been over 100 days since my stem cell transplant.
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My multiple myeloma diagnosis has been confirmed by a specialist.
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My multiple myeloma has returned or didn't respond after 3 treatments.
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I am 18 years old or older.
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My myeloma came back after initial treatment but is not resistant to therapy.
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I've had treatments including proteasome inhibitor, immunomodulatory drug, CD38 antibody, and high-dose chemo with stem cell support.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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)
Secondary outcome measures
overall response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Targeted MCARH109 CAR Modified T cellsExperimental Treatment1 Intervention
Patients will undergo leukapheresis of peripheral blood for further T cell enrichment; activation and genetic modification using a lentiviral vector encoding a GPRC5D targeted CAR (MCARH109). These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operation procedures. These modified T cell infusions will be administered 2-7 days following completion of conditioning chemotherapy.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,943 Previous Clinical Trials
589,082 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,150 Patients Enrolled for Multiple Myeloma
Sham Mailankody, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
65 Total Patients Enrolled
4 Trials studying Multiple Myeloma
65 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with plasma cell leukemia.I have been on steroids within the last two weeks.My kidney, liver, lung, and heart functions are all within normal ranges.You have an ongoing autoimmune disease.My myeloma has affected or is affecting my brain or spinal cord.I have a severe or active neurological condition.I had a transplant over 6 months ago and haven't needed strong medication for transplant-related complications in the last 3 months.I am fully active or can carry out light work.I have not had myeloma treatment for at least 14 days before my upcoming procedures.It has been over 100 days since my stem cell transplant.My myeloma got worse during or within 60 days after my last treatment.My blood counts meet the required levels without recent transfusions or growth support.My multiple myeloma diagnosis has been confirmed by a specialist.Your hemoglobin, white blood cell count, and platelet levels are within a certain range before starting the study.My multiple myeloma has returned or didn't respond after 3 treatments.I have not had radiation for at least 14 days before my planned cell collection or treatment start.I am not pregnant or breastfeeding and will use effective birth control during and for 1 year after the study.I have a heart condition.I have another active cancer besides the one being treated.I do not have any active, uncontrolled infections.I have been treated with therapies targeting GPRC5D.I am 18 years old or older.You have a specific type of disease that can be measured using certain criteria.I have HIV or active hepatitis B/C.My myeloma came back after initial treatment but is not resistant to therapy.I haven't had myeloma treatment in the last 6 months, except possibly CAR T cell therapy.I've had treatments including proteasome inhibitor, immunomodulatory drug, CD38 antibody, and high-dose chemo with stem cell support.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted MCARH109 CAR Modified T cells
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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