An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D Dual Target CAR-T Cells Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Zhejiang University0 sites9 target enrollmentApril 2022

ConditionsMultiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Zhejiang University
Enrollment: 9
Primary Endpoint: Incidence, severity AEs/SAEs
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with relapsed or refractory multiple myeloma

Registry

clinicaltrials.gov

Start Date

April 2022

End Date

March 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang University

Responsible Party

Principal Investigator

He Huang

Prof.

Zhejiang University

Eligibility Criteria

Inclusion Criteria

•Signed and dated, written informed consent prior to any study specific procedures;
•Estimated life expectancy of minimum of 12 weeks;
•ECOG 0-2;
•Diagnosed as multiple myeloma according to the IMWG criteria;
•Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
•If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
•urine M protein level ≥0.2g(200mg/24h);
•light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
•there are extramedullary lesions;
•Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);

Exclusion Criteria

•Active smoldering multiple myeloma;
•Active plasma cell leukemia;
•With organ amyloidosis;
•Central nervous system (CNS) involvement;
•Pregnant or breastfeeding;
•Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody
•Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg; Symptomatic heart failure per New York Heart Association Classification Class II, III or IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \> 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or \<50%;
•Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.

Outcomes

Primary Outcomes

Incidence, severity AEs/SAEs

Time Frame: 2 years after CAR-T cell infusion

Secondary Outcomes

Duration of response (DOR)(2 years after CAR-T cell infusion)
Concentration of CAR-T cells(2 years after CAR-T cell infusion)
Overall survival (OS)(2 years after CAR-T cell infusion)
Percentage of Patients With Negative Minimal Residual Disease (MRD)(2 years after CAR-T cell infusion)
Progression-free survival (PFS)(2 years after CAR-T cell infusion)
Objective response rate (ORR)(2 years after CAR-T cell infusion)