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

Phase 1

Not yet recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: BMCA and GPRC5D dual target CAR-T cells(OriC321)

• Registration Number: NCT05325801
• Lead Sponsor: Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13
• Primary Completion: 2024-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

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/ λ 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMCA and GPRC5D dual target CAR-T cells （OriC321）	BMCA and GPRC5D dual target CAR-T cells(OriC321)	-

Primary Outcome Measures

Name	Time	Method
Incidence, severity AEs/SAEs	2 years after CAR-T cell infusion

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	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
Concentration of CAR-T cells	2 years after CAR-T cell infusion
Overall survival (OS)	2 years after CAR-T cell infusion
Objective response rate (ORR)	2 years after CAR-T cell infusion