Overview

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

Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hrain Biotechnology Co., Ltd.
Collaborator:
Shanghai Changzheng Hospital
Treatments:
Cyclophosphamide
Fludarabine
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

- 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.