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Clinical Trials in China / NCT03455972
Active, not recruiting Phase 1/2

Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT

NCT03455972 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Phase 1/2
Started
2018-02-20
Last updated
2026-03-17

Condition(s) studied

Safety and Efficacy

Investigational drug(s) / intervention(s)

anti-CD19 and anti-BCMA CARImmunomodulatory drugs →

anti-CD19 and anti-BCMA CAR: Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (1×10e+7/kg on d0) and anti-BCMA CAR T cells as split-dose (total 5×10e+7/kg, 40% on d1 and 60% on d2)

Immunomodulatory drugs: Maintenance therapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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℃).

Primary outcome measure(s)

  • Incidence and severity of adverse events — Approximately 2 years
    Proportion of subjects with adverse events overall and by severity grade
  • PFS, response — every 6 months after first induction
    mPFS of all patients. PFS is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first. Percentage of patients with sCR. Response was graded according to IMWG response criteria.
  • CAR-T Pharmacokinetics — Minimum of 2 years after first induction
    Maximum transgene level, Time to peak transgene levelm, persistence

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital, Soochow University Suzhou Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03455972 on ClinicalTrials.gov ↗ ← All trials in China