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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05325801
• Other study ID #: Sirius
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2022
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. If IgG type MM, serum M protein =10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein =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/ ? FLC ratio is abnormal;

4. 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);

• Adequate organ functions

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• BMCA and GPRC5D dual target CAR-T cells(OriC321)
Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity AEs/SAEs		2 years after CAR-T cell infusion
Secondary	Concentration of CAR-T cells		2 years after CAR-T cell infusion
Secondary	Objective response rate (ORR)		2 years after CAR-T cell infusion
Secondary	Progression-free survival (PFS)		2 years after CAR-T cell infusion
Secondary	Duration of response (DOR)		2 years after CAR-T cell infusion
Secondary	Overall survival (OS)		2 years after CAR-T cell infusion
Secondary	Percentage of Patients With Negative Minimal Residual Disease (MRD)		2 years after CAR-T cell infusion