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Also known as CAR T Infusion, CAR T Therapy, CAR T-cell Therapy, Chimeric Antigen Receptor T-cell Infusion
Chimeric Antigen Receptor T-Cell Therapy · 1 trial · 31 indications
Will be defined as a complete metabolic response (CMR), partial metabolic response (PMR), or no metabolic response (NMR) by Lugano 2014 PET-CT.
| Arm | Type | Description |
|---|---|---|
| Treatment (golcadomide, rituximab) | EXPERIMENTAL | ELIGIBLE FOR CAR-T: Patients receive golcadomide orally (PO) once daily (QD) on days 1-14 of each cycle and rituximab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and then on day 1 of all subsequent cycles. After 1 cycle, patients undergo leukapheresis and receive an additional cycle of golcadomide and rituximab (bridging therapy) prior to undergoing standard of care CAR-T therapy. Patients may also receive optional bridging therapy with golcadomide and rituximab per physician choice (1-2 cycles) prior to undergoing standard of care CAR-T therapy. INELIGIBLE FOR CAR-T: Patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab IV on days 1, 8, 15 and 22 of cycle 1 and then on day 1 of all subsequent cycles. Patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab IV on day 1 of each cycle. Patients ineligible for CAR-T after 5 cycles, receive golcadomide PO QD on days 1-14 of each cycle. See Detailed Description for more info. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Chimeric Antigen Receptor T-Cell Therapy | BIOLOGICAL | Undergo standard of care CAR-T therapy |
| Computed Tomography | PROCEDURE | Undergo CT or PET/CT |
| Golcadomide | DRUG | Given PO |
| Leukapheresis | PROCEDURE | Undergo leukapheresis |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Rituximab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Age ≥ 18 years * Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and/or refractory disease (Cheson et al. 2014) following treatment with one or two prior lin...