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

Sponsor
Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05325801
Collaborator
(none)
9
Enrollment
1
Arm
35
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: BMCA and GPRC5D dual target CAR-T cells(OriC321)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMCA and GPRC5D dual target CAR-T cells （OriC321）

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

Outcome Measures

Primary Outcome Measures

  1. Incidence, severity AEs/SAEs [2 years after CAR-T cell infusion]

Secondary Outcome Measures

  1. Concentration of CAR-T cells [2 years after CAR-T cell infusion]

  2. Objective response rate (ORR) [2 years after CAR-T cell infusion]

  3. Progression-free survival (PFS) [2 years after CAR-T cell infusion]

  4. Duration of response (DOR) [2 years after CAR-T cell infusion]

  5. Overall survival (OS) [2 years after CAR-T cell infusion]

  6. Percentage of Patients With Negative Minimal Residual Disease (MRD) [2 years after CAR-T cell infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
He Huang, Prof., Zhejiang University
ClinicalTrials.gov Identifier:
NCT05325801
Other Study ID Numbers:
  • Sirius
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Apr 13, 2022