NCT04706936

Brief Summary

This study evaluates the safety and efficacy of novel BCMA-targeted CAR-T cell therapy (CBG-002) for patients with relapsed or refractory multiple myeloma (r/r MM). CBG-002 is designed based on the fourth-generation of CAR-T techonology.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

December 3, 2020

Last Update Submit

February 2, 2023

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

BCMAChimeric antigen receptor T cellAdoptive cell therapy

Outcome Measures

Primary Outcomes (2)

  • Rate of grade 3 or 4 treatment related adverse effect

    All the CAR-T treatment related adverse events，including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.

    24 weeks after last dose of CAR-T treatment

  • Overall response rate (ORR) after treated by CAR-T treatment

    ORR will be assessed and graded by the international Myeloma Working Group (IMWG) Unified response criteria for multiple myeloma

    up to 2 years after CAR-T treatment

Secondary Outcomes (3)

  • Pharmacokinetics of CAR-T cells (implantation endpoint)

    up to 2 years after CAR-T treatment

  • Overall survival

    up to 2 years after CAR-T treatment

  • Progression free survival

    up to 2 years after CAR-T treatment

Study Arms (1)

Anti-BCMA CAR-T (CBG-002)

EXPERIMENTAL

All subjects were intravenous administrated with CBG-002.

Biological: anti-BCMA CAR-TDrug: CyclophosphamidDrug: Fludarabine

Interventions

anti-BCMA CAR-TBIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-BCMA CAR.

Also known as: CBG-002 CAR-T
Anti-BCMA CAR-T (CBG-002)
CyclophosphamidDRUG

300mg/m2/d

Anti-BCMA CAR-T (CBG-002)
FludarabineDRUG

30mg/m2/d

Anti-BCMA CAR-T (CBG-002)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with relapsed/refractory multiple myeloma aged 18-75 years;
  • BCMA expression ≥50% in bone marrow samples confirmed by Flow Cytometry or IHC is positive for BCMA expression;
  • Relapsed/refractory patients who meet the following conditions:
  • Ineffective or disease progression after receiving bortezomib (proteasome inhibitor) and lenalidomide for 3 courses;
  • Ineffective or disease progression after receiving the original treatment plan for 3 courses;
  • The interval between the last treatment and disease progression is more than 30 days;
  • There is currently no indication for hematopoietic stem cell transplantation, or the patient refuses to do hematopoietic stem cell transplantation;
  • The definition of disease progression refers to the "2014 IMWG Standards", and at least meets the following 1 items:
  • e.1 Serum M protein ≥ 0.5 g/dL;
  • e.2 Urine M protein ≥ 200 mg/24 h;
  • e.3 If the serum FLC ratio is abnormal, the patient's FLC level ≥ 10 mg/dL (100 mg/L);
  • e.4 Evaluable plasmacytoma confirmed by biopsy;
  • e.5 Increase in the proportion of bone marrow plasma cells ≥25% (absolute increase ≥10%);
  • e.6 Bone marrow plasma cells account for 30% of the total bone marrow cells;
  • Estimated survival time\> 12 weeks;
  • +12 more criteria

You may not qualify if:

  • Subjects who meet any of the following criteria cannot be selected for this study:
  • Systemic treatment such as lymphatic depletion with cyclophosphamide and fludarabine within 2 weeks before enrollment or single cell collection, or cell therapy within 8 weeks before treatment;
  • HCV or HIV positive; any uncontrollable active infection, including active tuberculosis, HBV DNA level ≥1×103 copies/mL;
  • Active infections occurred within 72 hours before cleansing; as long as there is no evidence of active infection and antibiotics are not in the list of prohibited drugs, subjects who continue to use preventive antibiotics, antifungal drugs or antiviral drugs are not excluded;
  • The current systemic use of cyclosporine or steroid drugs such as dexamethasone, recent or current use of inhaled steroids is not excluded;
  • Renal insufficiency, serum creatinine\>1.5 upper limit of normal (ULN);
  • Liver insufficiency, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>2.5 times ULN and direct bilirubin\>1.5 times ULN;
  • Hyponatremia, blood sodium \<125 mmol/L;
  • Baseline serum potassium \<3.5 mmol/L (potassium supplementation can be given before participating in the study, and serum potassium recovery above this standard is not excluded);
  • Pregnant or lactating women;
  • Other serious diseases that may restrict subjects from participating in this trial (such as central nervous system disease, severe heart insufficiency, myocardial obstruction or unstable arrhythmia or unstable angina, gastric ulcer in the past 6 months , Active autoimmune diseases, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

    PMID: 37192741DERIVED

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Wenbin Qian

    2nd Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Qian

CONTACT

13605801032qianwb@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

January 13, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)