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

NCT ID: NCT05325801

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2025-03-31

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

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321

Interventions

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

Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321

Intervention Type: BIOLOGICAL

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Sirius

Identifier Type: -

Identifier Source: org_study_id