Engineered immune cells take aim at Hard-to-Treat multiple myeloma
NCT ID NCT03455972
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving patients with high-risk multiple myeloma specially engineered T-cells (CAR T-cells) after a stem cell transplant can safely improve outcomes. The T-cells are designed to target two proteins on myeloma cells, CD19 and BCMA. Researchers are monitoring side effects and how long the cancer stays under control in 43 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anti-CD19 and anti-BCMA CAR T-cells
- What this could lead to
- If successful, this could offer a more effective way to control high-risk multiple myeloma after a stem cell transplant, potentially extending remission and survival.
- What could go wrong
- This is an early-phase trial with only 43 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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43 people
The number who actually took part.
- Started
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Feb 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previously treatment with any gene therapy products. * 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). * Patients with fever of unknown origin (T\>38℃).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000, China
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