Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurren… (NCT05411497) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurrent or Refractory Multiple Myeloma
United States5 participantsStarted 2022-06-20
Plain-language summary
This phase I trial tests the safety, side effects and best dose of MUC1-activated T cells in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory) and is positive for expression of the MUC1 protein. T-cells are infection fighting blood cells that can kill cancer cells. MUC1-activated T-cells are made from the body's own T cells. The manufactured T-cells are made to target the MUC1 genetic marker and may help the body's immune system identify and kill cancer cells.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* MUC1 expression in multiple myeloma tumor cells verified by immunohistochemistry (IHC) or flow cytometry (FCM). Heterogeneous tumor expression of MUC1 is acceptable
* Relapsed or refractory multiple myeloma previously treated with or intolerant to at least three prior lines of therapy and be relapsed or intolerant to a proteasome inhibitor, an immune modulatory drug (IMiD), and a CD38 antibody. Patients must be at least 90 days since an autologous stem cell transplant, if performed
* Patients must have measurable disease per IMWG criteria on study entry, which must include at least one of the following:
* Serum M-spike \>= 0.5 g/dL Patients with IgA, IgM or IgD myeloma in whom serum protein electrophoresis is deemed unreliable for routine M-protein quantitation may be considered eligible if total serum IgA, IgM or IgD level is elevated above normal range and parallels disease course
* 24-hour urine M-spike \>= 200 mg
* Involved serum free light chain (FLC) \>= 10 mg/L with an abnormal free light chain ratio
* Bone marrow plasma cells \> 30%
* Patients with extramedullary disease:
* 1 lesion that has a single diameter of \>= 2 cm measured by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT
* Skin lesions can be used if the area is \>= 2cm in at least one diameter and meas…