NCT03455972Active, not recruitingPhase 1/2
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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 high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 19 Feb 2018
- Start date
- 20 Feb 2018
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Multiple myeloma
- NCT number
- NCT03455972
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 43
- From 20 Feb 2018 to the primary completion date, 31 Dec 2027
- 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
- Multiple myeloma patients eligible for auto-HSCT.
- High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).
- Expected survival ≥ 3 months.
- Creatinine \< 2.0 mg/dl.
- Blood coagulation function: PT and APTT \<2x normal.
- Arterial blood oxygen saturation\>92%.
- ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal
- Karnofsky scores ≥ 60 and ECOG score≤2.
- Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- Patients should not take 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 · Does not accept 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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.