Recurrent/refractory multiple myeloma (r/r MM) patients received infusion of BCMA-GPRC5D CAR-T cells

Andie Fu

The recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients will be treated with APX005M.

APX005M dosing will begin at 0.1 mg/kg, the APX005M dose may be increased (0.3, 0.45, 0.6 mg/kg) or decreased (0.03 mg/kg) in subsequent cohorts until the maximum tolerated dose (MTD) is reached or until dose level 3 (0.6 mg/kg) is complete without the MTD being defined.

APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first.

APX005M treatment for recurrent or refractory primary malignant CNS tumor patients

The newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) patients will be treated with APX005M.

The starting dose of APX005M for the DIPG patients will be one dose level below the recommended phase II dose (RP2D) determined in Stratum 1 patients. The dose may be decreased or increased to the RP2D established in Stratum 1.

APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first.

APX005M treatment for newly diagnosed DIPG patients

다발성 골수종 환자의 감염 예방을 위한 새로운 항체 치료의 효과와 안전성을 평가하는 중재적 임상시험입니다.

Immunoglobulin support (subcutaneous or intravenous)

Target trough IgG level of 8-10 g/L

Immunglobulin support (subcutaneous or intravenous)

Target trough IgG level 4-6 g/L

No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.

If, during follow-up, the patient presents recurrent or severe infections and/or total IgG level less 4 g/L, crossover to group A or B

재발성/불응성 다발성 골수종(r/r MM) 환자들에게 BCMA-GPRC5D CAR-T 세포를 주입했습니다.

재발성 또는 불응성 원발성 악성 중추신경계 종양 환자에 대한 APX005M 치료, 새로 진단된 DIPG 환자에 대한 APX005M 치료

목표 최저 IgG 수치 8-10g/L, 목표 최저 IgG 수치 4-6g/L, 재발성 또는 중증 감염 병력 없음, 총 IgG 수치 4g/L 이상