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

NCT03943472 | Unknown Early Phase 1 DMC

• 1 other identifier: anti-BCMA CART
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

BCMA; CAR-T; multiple myeloma; Relapsed /Refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

  8 weeks

• Duration of CAR-positive T cells in circulation

  6 months

Study Arms (2)

anti-BCMA CAR-T

EXPERIMENTAL

Administration of anti-BCMA CAR-T cells to patients with multiple myeloma

Biological: Anti-BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

anti-BCMA CAR-T+ Immune inhibitors

EXPERIMENTAL

Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma

Biological: Anti-BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Immune inhibitors

Interventions

Anti-BCMA CAR-T cells BIOLOGICAL

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

anti-BCMA CAR-T; anti-BCMA CAR-T+ Immune inhibitors

Fludarabine DRUG

30mg/m2/d

anti-BCMA CAR-T; anti-BCMA CAR-T+ Immune inhibitors

Cyclophosphamide DRUG

300mg/m2/d

anti-BCMA CAR-T; anti-BCMA CAR-T+ Immune inhibitors

Immune inhibitors DRUG

Immune inhibitors

anti-BCMA CAR-T+ Immune inhibitors

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hrain Biotechnology Co., Ltd.: lead
• Shanghai Changzheng Hospital: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabine; Cyclophosphamide; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Xuedong Sun

CONTACT

021-58552006; sunxuedong@dashengbio.com

Weijun Fu

CONTACT

021-81885423; fuweijun2010@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: July 8, 2019
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)