A Study of CAR-T Cells Targeting Both BCMA and GPRC5D in Treatment of Relapsed or Refractory Multiple Myeloma

Last updated: April 5, 2022
Sponsor: Zhejiang University
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Cancer

Multiple Myeloma

Treatment

N/A

Clinical Study ID

NCT05325801
Sirius
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 validatedimmunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should havemeasurable disease. At least meet one of the following criteria:
  1. If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum Mprotein ≥5g/L;
  2. urine M protein level ≥0.2g(200mg/24h);
  3. light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratiois abnormal;
  4. there are extramedullary lesions;
  • Subjects have had at least 3 prior lines of therapy including chemotherapy based onproteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
  • Adequate organ functions

Exclusion

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-positiveand detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody andhepatitis 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, IIIor IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricularejection 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 studytreatment. Exceptions here are as follows: the disease under study; adequately treatedbasal or squamous cell carcinoma of the skin; cancer of the cervix in situ.

Study Design

Total Participants: 9
Study Start date:
April 01, 2022
Estimated Completion Date:
March 31, 2025