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

NCT05325801 | Unknown Phase 1

• 1 other identifier: Sirius
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Incidence, severity AEs/SAEs

  2 years after CAR-T cell infusion

Secondary Outcomes (6)

• Concentration of CAR-T cells

  2 years after CAR-T cell infusion

• Objective response rate (ORR)

  2 years after CAR-T cell infusion

• Progression-free survival (PFS)

  2 years after CAR-T cell infusion

• Duration of response (DOR)

  2 years after CAR-T cell infusion

• Overall survival (OS)

  2 years after CAR-T cell infusion

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Adequate organ functions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 13, 2022

Record last verified: 2022-04