Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

Multiple Myeloma in Relapse Clinical Trial

Official title:

Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03706547
• Other study ID #: SHZS-MM002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 30, 2018
• Est. completion date: December 2021

Study information

• Verified date: October 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Zheng Wei, M.D.
• Phone: +(86)-21 64041990
• Email: wei.zheng[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Description:

Primary Objectives

1. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.

Secondary Objectives

1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.

2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Expected survival > 12 weeks

• Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)

• Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma

• Exited measurable lesions and in accordance with one of the following test indicators:

serum M protein=1 g/dl; urine M protein=200 mg/24h; serum free light chain=10 mg/dl; diagnosis of plasmacytoma by biopsy

• The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days

• At least 90 days after stem cell transplantation

• Clinical performance status of ECOG score 0-2

• Creatinine=2.0 mg/dl

• Bilirubin=2.0 mg/dl

• The ALT/AST value is lower than 2.5-fold of normal value

• Accessible to intravenous injection, and no white blood cell collection contraindications

• Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom

• 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg:

Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion

• Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

• Patients with symptoms of central nervous system

• Patients with second malignancies in addition to multiple myeloma

• Active hepatitis B or C, HIV infections

• Any other active diseases could affect the enrollment of this trial

• Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment

• Patients with organ failure

• Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy

• A history of mental illness and poorly controlled

• Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

• Patients who are accounted by researchers to be not appropriate for this test

• Subjects suffering disease affects the understanding of informed consent or complying with study protocol

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma Progression
• Neoplasms, Plasma Cell

Intervention

Biological:
• anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

Drug:
• Fludarabine
30mg/m2/d
• Cyclophosphamide
300mg/m2/d

Locations

Country	Name	City	State
China	Department of Hematology ,Fudan University Zhongshan Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Peng Liu	Hrain Biotechnology, Shanghai East Hospital

Country where clinical trial is conducted

China, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0	6 months
Secondary	Overall remission rate defined by the standard response criteria for myeloma for each arm	Overall remission rate defined by the standard response criteria for myeloma for each arm	8 weeks
Secondary	Duration of CAR-positive T cells in circulation	Duration of CAR-positive T cells in circulation	6 months