A phase I/II open label, multicenter study evaluating the feasibility, safety and efficacy of point-of-care manufactured antiBCMA CAR T cells (GLPG5301; BCMACP03) in subjects with relapsed/refractory Multiple Myeloma (RRMM)

Conditions

relapsed/refractory Multiple Myeloma

Brief summary

Phase I dose-escalation phase: Incidence of (serious) adverse events ([S]Aes), Dose-limiting toxicities (DLTs) until Day 28, Phase II dose-expansion phase: Objective response (OR) until 2 years post GLPG5301 infusion per International Myeloma Working Group (IMWG) criteria

Detailed description

Type, frequency and severity of (S)AEs (including AEs of special interest [AESI]) and clinically significant laboratory abnormalities, Best overall response (BOR) until 2 years post GLPG5301 infusion per IMWG criteria, Complete response (CR) until 2 years post GLPG5301 infusion per IMWG criteria, Progression-free survival (PFS), Duration of response (DOR), Overall survival (OS), Minimal Residual Disease (MRD), Soluble BCMA (sBCMA) levels, Time to Response (TTR), in subjects with a response, Levels of GLPG5301 in blood at peak and over time, Levels of chemokines and cytokines in serum over time, Number of successfully manufactured GLPG5301 products within the predefined release specifications, Change from baseline in measurement of health-related QoL as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EQ-5D-5L, and EORTC QLC-MY20

Niels W.C.J. van de Donk, Sébastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques et al. (6 authors)

Blood2023-11-021 citations

10.1182/blood-2023-189001

Interventions

DRUGBCMACP03

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I dose-escalation phase: Incidence of (serious) adverse events ([S]Aes), Dose-limiting toxicities (DLTs) until Day 28, Phase II dose-expansion phase: Objective response (OR) until 2 years post GLPG5301 infusion per International Myeloma Working Group (IMWG) criteria	—

Secondary

Measure	Time frame
Type, frequency and severity of (S)AEs (including AEs of special interest [AESI]) and clinically significant laboratory abnormalities, Best overall response (BOR) until 2 years post GLPG5301 infusion per IMWG criteria, Complete response (CR) until 2 years post GLPG5301 infusion per IMWG criteria, Progression-free survival (PFS), Duration of response (DOR), Overall survival (OS), Minimal Residual Disease (MRD), Soluble BCMA (sBCMA) levels, Time to Response (TTR), in subjects with a response, Levels of GLPG5301 in blood at peak and over time, Levels of chemokines and cytokines in serum over time, Number of successfully manufactured GLPG5301 products within the predefined release specifications, Change from baseline in measurement of health-related QoL as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EQ-5D-5L, and EORTC QLC-MY20	—

Measure

Time frame

Type, frequency and severity of (S)AEs (including AEs of special interest [AESI]) and clinically significant laboratory abnormalities, Best overall response (BOR) until 2 years post GLPG5301 infusion per IMWG criteria, Complete response (CR) until 2 years post GLPG5301 infusion per IMWG criteria, Progression-free survival (PFS), Duration of response (DOR), Overall survival (OS), Minimal Residual Disease (MRD), Soluble BCMA (sBCMA) levels, Time to Response (TTR), in subjects with a response, Levels of GLPG5301 in blood at peak and over time, Levels of chemokines and cytokines in serum over time, Number of successfully manufactured GLPG5301 products within the predefined release specifications, Change from baseline in measurement of health-related QoL as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EQ-5D-5L, and EORTC QLC-MY20

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Countries

Belgium, Netherlands

Outcome results

None listed