NCT03196414RecruitingPhase 1/2
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 2 May 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 19 Oct 2016
- Start date
- 1 Sept 2016
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Multiple myeloma
- NCT number
- NCT03196414
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From 1 Sept 2016 to the primary completion date, 30 Sept 2026
- 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 use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products
Other illness
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- History of myocardial infarction and severe arrhythmia in half a year
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
Other
- Pregnant or lactating women
- Patients with fever of unknown origin (T \> 38℃)
Who the study is looking for
- CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
- Relapsed and/or refractory multiple myeloma.
- Relapsed after prior autologous or allogenic SCT.
- Expected survival ≥ 3 months
- Creatinine \< 2.0 mg/dl
- Blood coagulation function: PT and APTT \< 2x normal
- Arterial blood oxygen saturation \> 92%
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
- Karnofsky scores ≥ 60 and ECOG score ≤ 2
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion.
- Voluntary informed consent is given
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital SooChow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.