BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943472
• Other study ID #: anti-BCMA CART
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 8, 2019
• Est. completion date: May 2022

Study information

• Verified date: August 2021
• Source: Hrain Biotechnology Co., Ltd.
• Contact: Xuedong Sun
• Phone: 021-58552006
• Email: sunxuedong[@]dashengbio.com
• 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-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.

Description:

Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Expected survival > 12 weeks
• Diagnosis of Multiple Myeloma by MWG criteria 20
• Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
• Important organs function enough to tolerate this therapy
• At least 90 days after stem cell transplantation
• 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
• 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
• Suffering severe cardiovascular or respiratory disease
• Poorly controlled hypertension
• Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
• A history of mental illness and poorly controlled
• Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
• Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
• Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
• 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
• Active systemic infections or uncontrolled infection within 14 days prior enrollment
• Subjects suffering disease affects the understanding of informed consent or complying with study protocol.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR

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

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Hrain Biotechnology Co., Ltd.	Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0	6 months
Secondary	Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm	Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm	8 weeks
Secondary	Duration of CAR-positive T cells in circulation	Duration of CAR-positive T cells in circulation	6 months