BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma

NCT ID: NCT03093168

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2020-02-29

Brief 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.

Detailed Description

Primary Objectives

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

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

3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.

Secondary Objectives

1. To assess the bone marrow and tumor migration of BCMA CAR-T cells.

2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro

3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.

4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

anti-BCMA CAR-T

Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma

Group Type: EXPERIMENTAL

Anti-BCMA CAR-T cells

Intervention Type: BIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-BCMA CAR

Fludarabine

Intervention Type: DRUG

dose: 25mg/m2/d

Cyclophosphamide

Intervention Type: DRUG

Dose: 40mg/kg

Interventions

Anti-BCMA CAR-T cells

Retroviral vector-transduced autologous T cells to express anti-BCMA CAR

Intervention Type: BIOLOGICAL

Fludarabine

dose: 25mg/m2/d

Intervention Type: DRUG

Cyclophosphamide

Dose: 40mg/kg

Intervention Type: DRUG

Eligibility Criteria

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
• Clinical performance status of ECOG score 0-4
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hrain Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Province of TCM

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhi Cheng, M.D.

Role: primary

clinicaltrials.chengzhi@outlook.com

+(86)-139-3852-6995

References

Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

Reference Type: DERIVED

PMID: 37192741 (View on PubMed)

Other Identifiers

anti-BCMA CART

Identifier Type: -

Identifier Source: org_study_id