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A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Study Purpose

Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed 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 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
Those who voluntarily participated in this trial and provided informed consent;
  • - 2.
Gender unlimited，18
  • - 3.
    • Estimated life expectancy of minimum of 12 weeks;
    • - 4.
    ECOG 0-2;
    • - 5.
    Diagnosed as multiple myeloma according to the IMWG criteria;
    • - 6.
    Subjects failed treatment with at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors (PIs) ，immunomodulatory agents (IMiDs) and CD38 antibody）, or recived the above three treatment methods experienced disease progression or recurrence during the most recent treatment process or within 6 months after the end of treatment, Difficulty in treatment includes primary difficulty in treatment ( patient has not achieved minimal remission or disease progression during treatment) or secondary difficulty in treatment (patient develops disease progression within 60 days after completion of treatment);
    • - 7.
    Women have a negative urine pregnancy test before the start of medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up;
    • - 8.
    The blood routine meets the following standards: 1. Lymphocyte count>0.3×10e9/L; 2. Neutrophils ≥0.5×10e9/L; 3. Hemoglobin ≥60g/L; 4. Platelet ≥30×10e9/L.

    Exclusion Criteria:

    • - 1.
    History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
    • - 2.
    Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
    • - 3.
    Pregnant (or lactating) women;
    • - 4.
    Patients with HIV infection;
    • - 5.
    Active infection of hepatitis B virus or hepatitis C virus;
    • - 6.
    Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
    • - 7.
    The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
    • - 8.
    Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
    • - 9.
    Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;
    • - 10.
    Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
    • - 11.
    Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
    • - 12.
    Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
    • - 13.
    Patients received allogeneic stem cell therapy;
    • - 14.
    Any unsuitable to participate in this trial judged by the investigator.

    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.

    		 NCT06084962
    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 1
    Lead Sponsor

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

    		 He Huang
    Principal Investigator

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

    		 He Huang, MD
    Principal Investigator Affiliation 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.

    		 Relapse/Refractory Multiple Myeloma
    Additional Details

    In this study, 60 patients with relapsed refractory multiple myeloma were proposed to undergo DeepTag-GPRC5D CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of DeepTag-GPRC5D CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on DeepTag-GPRC5D CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

    Arms & Interventions

    Arms

    Experimental: Administration of DeepTag-GPRC5D Targeted CAR T-cells

    Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

    Interventions

    Biological: - DeepTag-GPRC5D Targeted CAR T-cells

    Each subject receive DeepTag-GPRC5DTargeted 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 of medical college of zhejiang university

    Hangzhou, Zhejiang, 310000

    Site Contact

    He Huang, MD

    hehuangyu@126.com

    86-13605714822

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