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

NCT03455972 | Active Not Recruiting Phase 1

• 1 other identifier: myeloma-03
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety and Efficacy

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events

  Proportion of subjects with adverse events overall and by severity grade

  Approximately 2 years

• PFS, response

  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.

  every 6 months after first induction

• CAR-T Pharmacokinetics

  Maximum transgene level, Time to peak transgene levelm, persistence

  Minimum of 2 years after first induction

Secondary Outcomes (4)

• MRD negative conversion ratio and persistence

  every 3 months for first year, then every 6 months

• lymphocyte subsets analysis

  Minimum of 2 years

• immune mutation

  Minimum of 2 years

• Patients quality of life

  within 1 year post CART infusion

Study Arms (1)

anti-CD19 and anti-BCMA CAR

EXPERIMENTAL

Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (on d0) and anti-BCMA CAR T cells as split-dose (40% on d1 and 60% on d2)

Biological: anti-CD19 and anti-BCMA CAR; Drug: Immunomodulatory drugs

Interventions

anti-CD19 and anti-BCMA CAR BIOLOGICAL

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)

anti-CD19 and anti-BCMA CAR

Immunomodulatory drugs DRUG

Maintenance therapy

Also known as: IMiDs

anti-CD19 and anti-BCMA CAR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women.
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• 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℃).

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

Immunomodulating Agents

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• depei wu

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 7, 2018
• Study Start: February 20, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-12

Locations

CN (1)