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A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Study Purpose

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
Age and gender unlimited;
  • - 2.
According to the IMWG2014 standard, diagnosis as multiple myeloma;
  • - 3.
According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
  • - 4.
Abnormal plasmocyte BCMA expression positive;
  • - 5.
Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
  • - 6.
The subject has no lung activity infection;
  • - 7.
Expected life time is more than 3 months;
  • - 8.
ECOG score 0-2 score;
  • - 9.
Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

  • - 1.
Patients with the history of epilepsy or other CNS disease;
  • - 2.
Patients with prolonged QT interval time or severe heart disease;
  • - 3.
Pregnant or breastfeeding;
  • - 4.
Active infection with no cure;
  • - 5.
Patients with active hepatitis B or C infection;
  • - 6.
Previously treated with any genetic therapy;
  • - 7.
The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • - 8.
Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
  • - 9.
Those who suffer from other uncontrolled diseases are not suitable to join the study;
  • - 10.
HIV infection;
  • - 11.
Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05712083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 He Huang, MD
Principal Investigator Affiliation First Affiliated Hospital of Zhejiang University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma, New Diagnosis Tumor
Additional Details

This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy

Arms & Interventions

Arms

Experimental: Treatment Group

This is a single arm clinical trial.

Interventions

Drug: - BCMA CAR-T cells

Each subject receive BCMA CAR T-cells by intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003

Site Contact

He Huang, MD

hehuangyu@126.com

86-13605714822

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