Multiple myeloma (MM) is a malignant hematological tumor originating from plasma cells in the bone marrow and is the most common type of plasma cell disorder. The disease is characterized by the abnormal proliferation of clonal plasma cells and the abnormal secretion of monoclonal immunoglobulins (M protein), and can affect the bones, kidneys, hematopoietic system, and immune function.

Currently, the main treatments for multiple myeloma (MM) include standard drug therapy, autologous hematopoietic stem cell transplantation, and traditional cellular immunotherapy. Although these strategies have improved patient outcomes to some extent, they still have significant limitations. For example, single-antigen targeted therapy is prone to antigen escape, HLA restrictions limit the scope of patient application, and the bone marrow immunosuppressive microenvironment weakens the anti-tumor function of T cells, making relapse and drug resistance difficult to avoid.

HLA-independent TCR-T cell therapy is expected to effectively overcome the above limitations by breaking through the reliance on HLA typing and integrating multi-target antigen recognition and TCR-level signal activation mechanisms. This strategy can not only reduce the risk of antigen escape and significantly expand patient coverage, but may also enhance the sustained killing ability of T cells in the immunosuppressive bone marrow microenvironment, thereby providing a more durable and universal immunotherapy option for patients with relapsed/refractory multiple myeloma (R/R MM).

We are assisting in the recruitment of eligible patients for a prospective clinical study evaluating an innovative HLA-independent TCR-T cell therapy targeting BCMA, NKG2D ligands (NKG2DL), and FAP in patients with relapsed or refractory multiple myeloma (R/R MM).

Treatment Protocol

This study is an exploratory, interventional clinical trial conducted in a single-arm design. Participants enrolled will receive HLA-independent Hi-TCR-T cell therapy, an advanced engineered T-cell treatment developed for patients with relapsed or refractory multiple myeloma (R/R MM). The therapy is delivered through one or more intravenous infusions, administered according to the study protocol, with close monitoring to ensure safety and support throughout treatment.

Intervention Overview

The Hi-TCR-T cells are genetically modified to recognize and target multiple disease-associated antigens, including BCMA, NKG2D ligands (NKG2DL), and FAP. This multi-target design enhances tumor recognition, reduces the risk of antigen escape, and allows the therapy to address both malignant plasma cells and components of the tumor microenvironment.

• HLA-independent recognition: Suitable for a broad patient population without HLA matching.
• Multi-target approach: Designed to address tumor cells and components of the tumor microenvironment simultaneously.
• Investigational therapy: Administered under controlled clinical study conditions with close safety monitoring.

More about HLA-independent TCR-T Cell Therapy

Treatment Process

• Pre-screening andEligibility Assessment:
  Initial review of medical history and prior treatments
  Evaluation of key eligibility criteria
  Confirmation of study suitability by the clinical research team
• Cell Collection and Manufacturing:
  Collection of peripheral blood cells
  Manufacturing of the investigational TCR-T cell product in a qualified facility
• TCR-T Cell Infusion:
  Single or protocol-defined infusion of the engineered TCR-T cells
  In-hospital observation for early safety monitoring
  Assessment for potential treatment-related reactions
• Follow-up and Long-term Monitoring:
  Ongoing monitoring of immune cell persistence and disease status
  Long-term follow-up in accordance with the study protocol.

Patient Recruitment Criteria

Treatment Cost

This clinical study is conducted as a self-funded treatment program. Patients who choose to participate will be responsible for the costs of the study treatment and associated medical examinations, including:

• Cost of HLA-Independent TCR-T cell preparation and injection treatment;
• Cost of necessary blood, imaging, and other laboratory tests during treatment;
• Fees for basic medical services during hospitalization (such as nursing care, medication, etc.).

For detailed fees, travel/visa support, accommodation and logistics, please contact us for a personalized consultation.

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