BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma

September 21, 2021 updated by: Weijun Fu, Shanghai Changzheng Hospital

Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma

This is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM. GC012F is an autologus dual chimeric antigen receptor T-cell(CAR-T) therapy that targets B-cell maturation antigen(BCMA) and CD19. This study comprises of a screening phase(less than or equal to 28 days prior to apheresis) followed by apheresis(will occur upon enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 to Day 84; and a Post-treatment Phase(Day 85 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of active MM as defined by any of following: a) serum M protein more than or equal to 10g/dL; b) urine M protein more than or equal to 200mg/24 h; c) involved serum free light chain more than or equal to 100mg/dL with abnormal serum kappa lambda ratio;
  2. Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or equal to 20%) detected by flow cytometry;
  3. High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or t(14;16);
  4. Estimated life expectancy more than or equal to 3 months;
  5. Absolute neutrophil count more than or equal to 1*10^9/L;
  6. Platelet count more than or equal to 25*10^9/L;
  7. Absolute lymphocyte count more than or equal to 1*10^8/L;
  8. Liver, kidney and cardiopulmonary functions meet the following requirements: a) Total bilirubin less than or equal to 2*ULN(except for Gilbert Syndrome); ALT and AST less than or equal to 2.5*ULN, maintenance of kidney function not depend on dialysis; c)Corrected serum calcium less than or equal to 12.5 mg/dL or free ion calcium less than or equal to 6.5mg/dL(1.6mmol/L);
  9. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
  10. Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T infusion;
  11. subjects must have signed writtern informed consent.

Exclusion Criteria:

  1. Accompanied by other unctrolled maligancies. Two exceptions to this criteria: Recepted radical therapy carcinoma without activity within 3 years before screening; fully treated skin non-melanoma;
  2. 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 intreat(eg., harm to health), or any situation that may prevent, limit or confuse the assessment;
  3. Convulsion or stoke within past 6 months;
  4. Any instability or systemic disease within 6 months prior to screening, including but not limited to congestive heart failure(New York heart association classification ≥ III)， unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction, LEVF<50%(assessed by an echocardiogram or multi-door circuit scan);
  5. Patients have central nervous system(CNS) metastases or CNS involvement(including cranial neuropathies or mass lesions and leptomeningeal disease);
  6. Subjects with positive HBsAg or HBcAb positive and peripheal 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;
  7. Presence or suspicious of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
  8. Activity of autoimmune disease (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), orhistory of autoimmune disease within the last 3 years;
  9. Clinical evidence of dementia or changes of mental state;
  10. Exist of pulmonary fibrosis;
  11. Allergy subjects or history of severe hypersensitivity;
  12. Oxgen inhalation requirement to maintain adequate oxygen saturation;
  13. Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis, during or 2 weeks after CAR-T infusion;
  14. Patients who are accounted to be not appropriate for this investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental:GC012F treatment
BCMA+ cytogenetic high-risk multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)*10^5/kg cells will be administered at Day 0
Biological: GC012F injection
GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and severity of adverse events after GC012F injection
Time Frame: Minimum 2 years after GC012F infusion
Minimum 2 years after GC012F infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of MRD negative patients after GC012F infusion
Time Frame: Minimum 2 years after GC012F infusion
Minimum 2 years after GC012F infusion
ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment
Time Frame: Minimum 2 years after GC012F infusion(Day0)
percent of subjects who achieving PR or better after GC012F infusion
Minimum 2 years after GC012F infusion(Day0)
Progression free survival after GC012F treatment
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Duration of response of subjects after GC012F treatment
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Overall survivalof subjects after GC012F treatment
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Cytokines in serum after GC012F infusion
Time Frame: Minimum 24 weeks after GC012F infusion(Day0)
Minimum 24 weeks after GC012F infusion(Day0)
Subset of lymphocytes in blood after GC012F infusion
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Anti-GC012F antibodies in blood after GC012F infusion
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)
Copies of GC012F in blood and bone marrow(if available) after GC012F infusion
Time Frame: Minimum 2 years after GC012F infusion(Day0)
Minimum 2 years after GC012F infusion(Day0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Changzheng Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gracell Biotechnology Shanghai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GBF003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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