TAA06 injection for treating B7-H3-positive neuroblastoma
An Open-label, Dose-escalation, and Dose-expansion Phase I Trial of TAA06 Injection in Patients With Relapsed/Refractory Neuroblastoma
This study is testing a new T cell injection called TAA06 to see if it can safely help patients with hard-to-treat neuroblastoma that has come back.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | PersonGen BioTherapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 2 sites (Jinan, Shandong and 1 other locations) |
| Trial ID | NCT05562024 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial evaluates the safety and tolerability of TAA06, a T cell injection targeting B7-H3, in patients with relapsed or refractory neuroblastoma. The trial employs a dose-escalation design, enrolling 12-18 subjects across three dose groups to assess dose-limited toxicity and determine the recommended phase 2 dose (RP2D). Following safety evaluations, the study will expand to include more patients at the RP2D to gather additional efficacy and pharmacokinetic data.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 year and older with B7-H3-positive relapsed or refractory neuroblastoma.
Not a fit: Patients who have not undergone at least one line of standard treatment or those with a Karnofsky/Lansky score below 60 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat neuroblastoma.
How similar studies have performed: While this approach is novel in targeting B7-H3, similar immunotherapy strategies have shown promise in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 1 year (including cut-off value), gender is not limited * Expected survival time ≥ 3 months * Karnofsky score (\> 16 years) or Lansky score (≤ 16 years) \> 60 points * Meet the clinical diagnostic criteria and be diagnosed as recurrent / refractory neuroblastoma. For first-line standard treatment, please refer to the consensus of experts in the diagnosis and treatment of Pediatric Neuroblastoma (Chinese Journal of Pediatric surgery, Volume 36, No. 1, 2015), the guidelines for the diagnosis and treatment of Pediatric Neuroblastoma of 2019 by the Health Commission, and the consensus of experts in the diagnosis and treatment of Pediatric Neuroblastoma (CCCG-NB-2021 Program) (Chinese Journal of Pediatric surgery, Volume 43, No. 7, 2022) 1. Recurrence is defined as the determination of recurrence after remission after at least first-line standard treatment. 2. Refractory is defined as a person who is not in remission after at least 4 cycles of chemotherapy (≥ 2 chemotherapeutic drugs, including alkylating agents and platinum) * The tumor tissue samples of the subjects were stained by immunohistochemistry (IHC) to show that the expression intensity of B7-H3 on the surface of tumor cell membranes was 1+ or above, and the proportion of positive staining of tumor cell membranes was ≥1% * At least one measurable lesion defined by RECISTv1.1 criteria, and at least one lesion that can be irradiated (except bone marrow) * Subjects with lesions only in the bone marrow may also be enrolled (without irradiation) * Liver and kidney function, cardiopulmonary function must meet the following requirements: 1. Total bilirubin ≤ 3 × ULN;ALT and AST ≤ 5 × ULN 2. Creatinine≤2 ULN 3. Left ventricular ejection fraction ≥ 50% 4. Blood oxygen saturation ≥ 92% * Patients and/or their guardians understand the trial and have signed informed consent Exclusion Criteria: * Patients who were judged by the investigator to require long-term immunosuppressive therapy at the time of screening * Cerebrovascular accident or seizure occurred within 6 months before signing the informed consent * Malignant tumors other than neuroblastoma, excluding carcinoma in situ * Hepatitis B surface antigen (HBsAg) positive; hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood type C Hepatitis virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive * Serious cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia * Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy * Presence of chronic progressive neurological disease * Patients who have not recovered from acute toxic effects of prior treatment * Active or uncontrolled infection requiring systemic treatment (except mild urogenital and upper respiratory tract infections) * Pregnancy-capable female subjects who plan to become pregnant within 2 years of cell reinfusion; or male subjects whose partners plan to become pregnant within 2 years of cell reinfusion * Those who have received CAR-T therapy or other gene-modified cell therapy before screening * Participated in other clinical studies within 1 month before screening * Subjects screened for evidence of central nervous system involvement * For patients with liver metastases, the distribution of liver metastases exceeds 1/2 of the liver * According to the judgment of the investigators, it does not meet the situation of cell preparation * Other circumstances deemed inappropriate by investigators
Where this trial is running
Jinan, Shandong and 1 other locations
- Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Not_yet_recruiting)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Qiang Zhao, Doctor — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: HuiMin Meng, Doctor
- Email: huimin.meng@persongen.com
- Phone: 86-18015580390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.