Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma

November 22, 2024 updated by: Carbiogene Therapeutics Co. Ltd.
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
38

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.
  • 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.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old≤ subjects < 75 years old, all genders;
  • Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF);
  • According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed;
  • Patients without indications for hematopoietic stem cell transplantation；
  • Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment;
  • Applicable only in the dose expansion phase: the surface BCMA positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %;
  • Patient has one or more measurable multiple myeloma lesions；
  • Patients must have appropriate organ function;
  • Patients had no contraindications to peripheral blood mononuclear cell collection;
  • ECOG score 0-2;
  • Expected survival ≥ 12 weeks;
  • Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating.

Exclusion Criteria:

  • Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product;
  • Severe cardiovascular and cerebrovascular diseases;
  • Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study;
  • Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF;
  • Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases;
  • Stroke or seizure occurred within 6 months prior to signing the ICF;
  • Previous plasma cell leukemia;
  • Multiple myeloma with extramedullary lesions;
  • Previous or screening examination showing amyloidosis;
  • Malignant tumor cells with T cell origin revealed by previous pathological examination;
  • Having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy;
  • Within 5 years prior to signing the ICF, patients with malignancies other than multiple myeloma;
  • Uncontrolled active infection;
  • Systemic disease judged by the investigator to be unstable;
  • More than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis;
  • Have used any CAR-T cell products or other genetically modified T cell therapies;
  • Previously received anti-tumor therapy against BCMA targets, including but not limited to antibodies, ADCs or CAR-T;
  • History of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the ICF;
  • Any non-hematologic toxicity due to prior therapy that cannot be restored to Grade ≤1 or baseline;
  • Patients with grade ≥2 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-GVHD treatment during the trial as judged by the investigator;
  • History of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the ICF, which may affect the safety evaluation or compliance as judged by the investigator;
  • Other conditions that are considered inappropriate by the investigator to participate in this study.

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: CBG002 CAR-T Cell Suspension
Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.
Drug: CBG002 CAR-T Cell Suspension
Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.

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
Measure Description
Time Frame
AEs.
Time Frame: 2 years post infusion
The severity and incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
2 years post infusion
DLT
Time Frame: 28 days post infusion
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
28 days post 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
Overall Response Rate (ORR)
Time Frame: 3 months post infusion
ORR at 3 months post infusion as evaluated by the Investigator
3 months post infusion
Progression free survival (PFS)
Time Frame: 2 years post infusion
The time from cell infusion to the first assessment of tumor progression or death from any cause
2 years post infusion
Overall survival (OS)
Time Frame: 2 years post infusion
The time from cell infusion to death due to any cause
2 years post infusion
Duration of remission (DOR)
Time Frame: 2 years post infusion
The time from the first assessment of the tumor for complete response and above efficacy to the first assessment of disease progression or death of any cause
2 years post infusion

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.
Carbiogene Therapeutics Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jie Jin, Zhejiang University

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 (Estimated)

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 26, 2024

Primary Completion (Estimated)

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.
October 25, 2027

Study Completion (Estimated)

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 22, 2028

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).
October 23, 2024

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.
November 22, 2024

First Posted (Estimated)

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 26, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
November 26, 2024

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.
November 22, 2024

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.
November 1, 2024

More Information

Terms related to this study

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.
  • CRKBY-102c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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