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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,793 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

Media Library

MCARH109 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04555551 — Phase 1

Multiple Myeloma Research Study Groups: Targeted MCARH109 CAR Modified T cells

Multiple Myeloma Clinical Trial 2023: MCARH109 Highlights & Side Effects. Trial Name: NCT04555551 — Phase 1

MCARH109 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04555551 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the administration of MCARH109 T cells been sanctioned by the FDA?

"Considering the lack of available data about MCARH109 T cells, our team has calculated a safety rating of 1. This is due to Infusion being in Phase 1 trials and only minimal evidence backing its efficacy and security."

Answered by AI

Are volunteers able to partake in this experiment currently?

"According to information available on clinicaltrials.gov, this medical study is not presently in need of participants. The trial was initially posted on September 8th 2020 and most recently amended on July 5th 2022. Though the current status does not allow for enrolment into this particular research project, there are over 800 other trials that seek volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma

2020. "MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04555551.