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

NCT ID: NCT03455972

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2023-12-31

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.

Detailed Description

Adults ages 18-75 with high risk Multiple Myelomas (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).

Design:

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory. Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the T cells through the IV within 3 days. Maintenance therapy with IMiDs was received after combined CAR T infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will visit the clinic 1, 2, 3, 6, 9 and 12 months after the infusion, then every 3 months until disease progression. A bone marrow sample will be taken at the 3-month visit.

Conditions

Safety and Efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 (on d0) and anti-BCMA CAR T cells as split-dose (40% on d1 and 60% on d2)

Group Type: EXPERIMENTAL

anti-CD19 and anti-BCMA CAR

Intervention Type: 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)

Immunomodulatory drugs

Intervention Type: DRUG

Maintenance therapy

Interventions

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)

Intervention Type: BIOLOGICAL

Immunomodulatory drugs

Maintenance therapy

Intervention Type: DRUG

Other Intervention Names

IMiDs

Eligibility Criteria

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℃).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

depei wu

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

chengcheng fu

Role: CONTACT

fuzhengzheng@suda.edu.cn

0086-0512-67781856

Facility Contacts

Fu chengcheng, Phd

Role: primary

fuzhengzheng@suda.edu.cn

13962191404

Shi xiaolan, Phd

Role: backup

shixiaolan@suda.edu.cn

Other Identifiers

myeloma-03

Identifier Type: -

Identifier Source: org_study_id