Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

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.

Patients will be admitted to Memorial Hospital as inpatient prior to the infusion of CAR T cells. The T cell infusion will be planned to start at 2 days following the completion of the conditioning chemotherapy (up to 7 days is allowed if clinically indicated to delay).Cohorts of 3-6 patients each will be treated with escalating doses of modified T cells.

Infusion of MCARH109 T cells

Sham Mailankody, MBBS

This study will test the safety of the study treatment, MCARH109, at different doses, to see which dose is safest in people, and to look for any good and bad effects of this treatment. The study treatment could stop the growth of the cancer, but it could also cause side effects.

This phase I trial will follow a standard 3-by-3 dose escalation design.

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

Phase I Trial of G Protein-coupled Receptor Class C Group 5 Member D (GPRC5D) Targeted MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. All patients treated in a dose cohort will be observed a minimum of 30 days before the T cell dose can be escalated.

Assessed by the IMWG 2016 criteria.The major criteria for determination of response to therapy in patients with MM include examination of the peripheral blood and bone marrow. Bone marrow aspirate and biopsy obtained at approximately 1 and 4 weeks following the T cell infusion will be used for disease response assessment. Definitions for response assessment will be as defined by the pending update to the international myeloma working group (IMWG) guidelines

Spots Global Cancer Trial Database for infusion of mcarh109 t cells