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NCT04541368Not yet recruitingEarly phase 1

A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

Clinical Trial for the Safety and Efficacy of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

Source: ClinicalTrials.gov · Last updated 10 Dec 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy

Status (registry)
Not yet recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
50 (estimated)
First submitted
19 Aug 2020
Start date
31 Dec 2020
Primary completion date
31 Dec 2023
Lead sponsor
Zhejiang University
NCT number
NCT04541368

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 50
  • From 31 Dec 2020 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
  • Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

Other illness

  • History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagicdiseases;
  • Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;

Lab values

  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;

Other

  • Subjects with any of the following exclusion criteria were not eligible for this trial:
  • Pregnant (or lactating) women;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Who the study is looking for

  • Histologically confirmed diagnosis of CS1+ multiple myeloma (MM):
    • Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;
    • Relapsed after hematopoietic stem cell transplantation;
    • Cases with recurrent positive minimal residual disease;
    • Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
  • Anticipated survival time more than 12 weeks;
  • Male or female aged 30-75 years;
  • Those who voluntarily participated in this trial and provided informed consent.

Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital, College of Medicine, Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.