Hodgkin Lymphoma CAR-T Cell Therapy BRD-01 Clinical Trial Application Approved in China

Hodgkin Lymphoma CAR-T Cell Therapy BRD-01 Clinical Trial Application Approved in China

On July 10, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced on its official website that the 1st-class innovative drug BRD-01, an anti-CD30 chimeric antigen receptor (CAR) autologous T-cell injection developed by Minghui (Nanjing) Gene Biotechnology Co., Ltd. (hereinafter referred to as “Minghui Gene”), has been approved for clinical trials. It is intended for the treatment of CD30-positive tumors such as Hodgkin lymphoma and anaplastic large cell lymphoma.

CD30 is expressed in various hematological malignancies, with relatively high levels in Hodgkin lymphoma and anaplastic large cell lymphoma. Other CD30-expressing cancers include T-cell lymphoma and some B-cell non-Hodgkin lymphomas. Previously, some antibody-drug conjugates (ADCs) or bispecific antibodies targeting CD30 have shown promising efficacy in clinical trials.

Drug Information

Drug Introduction: CD30 Chimeric Antigen Receptor Gene-Modified Autologous T-Cell Injection (BRD-01)

Study Group: BRD-01

Study Title

A Phase II Clinical Study to Evaluate the Efficacy and Safety of CD30-Targeted Chimeric Antigen Receptor Gene-Modified Autologous T-Cell Injection in Patients with Relapsed/Refractory Classical Hodgkin Lymphoma

Key Inclusion Criteria

1. Age 18-70 years (including limits), gender not restricted;

2. ECOG performance status 0-2;

3. Pathologically or cytologically confirmed classical Hodgkin lymphoma, meeting the following criteria for relapsed/refractory disease:

a) Relapsed or progressed after autologous stem cell transplantation;

b) For relapsed patients who have not received autologous stem cell transplantation, first-line treatment must include systemic multi-agent chemotherapy, and subsequent second-line or later treatments must include at least one regimen of systemic multi-agent chemotherapy, followed by relapse, progression, or intolerable toxicity. For relapsed patients, they must have received systemic multi-agent chemotherapy within 12 months prior to relapse;

c) For refractory patients, defined as a treatment course ≥2 cycles without achieving partial response (PR), or a treatment course ≥4 cycles without achieving complete response (CR). If the best response or reason for treatment discontinuation was progressive disease (PD), no minimum number of treatment cycles is required.

4. Immunohistochemistry shows CD30 expression;

5. Exclusion of patients with central nervous system or brain metastasis symptoms within 6 months prior to screening, or those who received treatment (radiation, surgery, or other therapies) for central nervous system or brain metastasis within 3 months prior to screening.

Patient Benefits

1. Free related examinations during the study

2. Free study drug

3. Regular follow-up by experts and related examinations

4. Guidance on the disease from authoritative medical experts

5. Travel allowance

Study Centers

Hubei, Shanghai.

Please consult the company’s local business staff or customer service for detailed study center information.

Required Documents for Enrollment

1. Pathology report, immunohistochemistry

2. Most recent inpatient medical record (admission and discharge)

3. Latest 1-2 imaging reports (CT, etc.)

4. Genetic testing report, if available

5. Blood test report within the last month (treatment history and imaging must meet criteria before providing)

6. Hepatitis B, hepatitis C, HIV, syphilis, etc.