NCT04236011

Brief Summary

This is a single arm, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM).

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
15

participants targeted

Target at P50-P75 for early_phase_1 multiple-myeloma

Timeline
Completed

Started Jan 2020

Typical duration for early_phase_1 multiple-myeloma

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

January 15, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

January 15, 2020

Last Update Submit

June 13, 2021

Conditions

Multiple Myeloma

Keywords

FastChimeric Antigen Receptor TBCMACD19Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events after GC012F infusion

    up to 24 weeks after GC012F infusion

Secondary Outcomes (9)

  • Percentage of MRD negative patients after GC012F treatment

    12 weeks, 24 weeks after GC012F infusion

  • ORR (PR, VGPR, CR and sCR) of patients receive GC012F treatment

    12 weeks, 24 weeks after GC012F infusion

  • Progression free survival after GC012F treatment

    12 weeks, 24 weeks after GC012F infusion

  • Copies and cell counts of CAR in blood and bone marrow (if available) after GC012F treatment

    Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion

  • Cytokines in serum after GC012F treatment

    Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion

  • +4 more secondary outcomes

Study Arms (1)

GC012F treatment

EXPERIMENTAL

BCMA+ R/R multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)\*10E5/kg cells will be administered at Day 0.

Biological: GC012F injection

Interventions

GC012F injectionBIOLOGICAL

GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CART cells will be administered intravenously.

GC012F treatment

Eligibility Criteria

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

You may qualify if:

  • Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria;
  • Diagnosis of MM with relapsed or refractory disease. Definition of Refractory/relapse:
  • Have had at least 3 prior lines of therapy or primary refractory as defined by Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Prior therapy should include PI and IMiD. Note: Patients should undergone at least have at least complete 1 cycle treatment in each line. Induction with or without hematopoietic stem cell transplant followed by maintenance therapy is considered a single line of therapy.
  • Have had at least 2 prior lines of therapy when refractory to both immunomodulatory drug (IMiD) and proteasome inhibitor(PI) (Refractory was defined by IMWG consensus criteria);
  • Estimated life expectancy ≥3 months;
  • Hemoglobin ≥ 8.0 g/dL;
  • Absolute neutrophil count ≥ 0.75\*10E9/L;
  • Platelet count ≥ 50\*10E9/L;
  • Absolute lymphocyte count ≥ 1\*10E8/L;
  • Liver, kidney and cardiopulmonary functions meet the following requirements: a)Total bilirubin ≤ 2×ULN(except for Gilbert Syndrome); ALT and/or AST ≤3 × ULN; b)clearance of serum creatinine ≥ 40 mL/min, calculated by Cockcroft-Gault; c)Corrected serum calcium ≤ 12.5mg/dL or free ion calcium ≤ 6.5mg/dL(1.6mmol/L);
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  • Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 100 days after CART cell infusion;
  • Subjects must have signed written, informed consent.

You may not qualify if:

  • Accompanied by other uncontrolled malignancies.There are two exceptions to this criterion: Recepted radical therapy carcinoma without activity within 3 years before screening; and fully treated skin non-melanoma;
  • Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best interests (e.g., harm to health), or any situation that may prevent, limit or confuse the assessment;
  • Convulsion or stoke within past 6 months;
  • Any instability of systemic disease within 6 months prior to screening, including but not limited to congestive heart failure (New York heart association (NYHA) classification ≥ III), unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction,LEVF\< 45% (assessed by an echocardiogram or multi-door circuit scan );
  • Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease);
  • Subjects with positive HBsAg or HBcAb postive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; syphilis primary screening antibody positive;
  • Presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
  • Activity of autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), orhistory of autoimmune disease within the last 3 years;
  • Clinical evidence of dementia or changes of mental state.
  • Exist of pulmonary fibrosis;
  • Allergy subjects or history of severe hypersensitivity;
  • Oxygen inhalation requirment to maintain adequate oxygen saturation;
  • Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis. during or 2 weeks after CART infusion;
  • Chemotherapy forbidden for cyclophosphamide or fludarabine;
  • Pregnant or lactating, or planning to have a pregnancy during or within 100 days after treatment;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaFasting

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesFeeding BehaviorBehavior

Central Study Contacts

Weijun Fu

CONTACT

(+86)13816052522fuweijun2010@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hematology Department

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 22, 2020

Study Start

January 16, 2020

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

June 15, 2021

Record last verified: 2021-06

Locations

CN(1)