RecruitingPhase 1Phase 2NCT05243212

Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

A Phase 1/2, Open-Label, Dose Escalation and Confirmation Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

Sponsor

Sheba Medical Center

Enrollment

75 participants

Start Date

Sep 19, 2021

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Relapse Multiple Myeloma

Summary

This is an open label, abbreviated (3+3) dose escalation study in subjects with RRMM, followed by an extension phase at the selected safe dose. The dose escalation stage will involve recruitment of 3 RRMM patients for 'low' dose (6 x 106 CAR-T cells/kg) CAR-T therapy. After 14 days of follow-up for each of the 3 subjects, the DSC will determine whether the next subject can be recruited. After 14 days follow-up for the 3rd subject, DSC will review data for the 3rd subject and consider the data for the first 3 subjects. In the absence of dose limiting toxicities (DLTs), the DSC may recommend recruitment of 3 subjects to be treated with the 'high' dose (9x106 CAR-T cells/kg) CAR-T therapy, with similar staggering. In case of DLTs in one of the 3 low dose subjects, the DSC may recommend to recruit an additional 3 low dose subjects (6 in total). If there are no additional DLTs in these 3 patients the low dose may be recommended by the DSC for the extension stage. However, further DLTs may prompt the DSC to recommend to modify the protocol, or to stop the study. In case of DLTs in one of the first 3 high dose subjects, the DSC may recommend to recruit an additional 3 high dose subjects.If there are no additional DLTs in these 3 patients, the high dose may be recommended by the DSC for the study extension stage. However, further DLTs may prompt the DSC to recommend continuation to the extension stage with the low dose, or to modify the protocol, or to stop the study. After completion of two months follow-up for the 6th subject in the low or high dose cohort (as applicable), and review of all the data for all subjects, following DSC recommendations, the Stage 2 extension phase of the study may recruit additional subjects, up to a maximum of 75 subjects for Stages 1 and 2, combined. DSC will review study data during the extension stage follow-up after 5 years to determine if additional safety follow-up is required.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests CAR-BCMA therapy — where a patient's own immune T cells are genetically modified to seek out and destroy multiple myeloma (a blood cancer) cells — in patients whose myeloma has come back or not responded to at least 3 prior treatment regimens. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - You have received at least 3 prior treatment regimens and your myeloma is still active - Your bone marrow shows at least 10% plasma cells (myeloma cells) - Your blood counts meet minimum thresholds - You are negative for HIV, hepatitis B (or on treatment), and hepatitis C **You may NOT be eligible if...** - You are HIV positive - You have active hepatitis B or C infection not under control - You are pregnant or breastfeeding - You are not willing to use birth control during and after the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCAR-BCMA

CAR-BCMA T-cells are genetically modified autologous T-cells directed to the B-cell maturation antigen (BCMA). CAR-BCMA T-cells identify and eliminate BCMA-expressing malignant plasma cells. Upon binding to BCMA-expressing cells, the CAR transmits a signal to promote T cell expansion, activation, persistence and elimination of malignant plasma cells.