Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276
ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. This study attempts to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting CD276 (B7-H3). The 4SCAR-CD276-modified T cells (4SCAR-276) can recognize and kill tumor cells through the recognition of CD276, a surface protein expressed at high levels on many types of tumors but at low levels on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-276 in treating refractory and/or recurrent tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
The CD276 antigen status of the tumor is determined for eligibility. Positive expression is defined by antibody staining results based on immunohistochemistry or flow cytometry analysis.
Body weight greater than or equal to 10 kg.
Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
Disqualifiers
Untreated central nervous system (CNS) metastasis: Patients with CNS tumor involvement that has been treated and/or is stable for at least 6 weeks following completion of therapy are eligible.
Previous treatment with other genetically engineered CD276-CAR T cells or CD276 antibody therapy.
Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
Patients who require systemic corticosteroid or other immunosuppressive therapy.
Trial design
Design model
Single group
Treatments tested in this trial
4SCAR-276
Biological/VaccineThe 4SCAR-276 T cells can recognize and kill tumor cells through the recognition of CD276 .This study will evaluate the side effects and effective doses of 4SCAR-276 T cells in treating refractory and recurrent solid tumors
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Effectiveness of 4SCAR-276 T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with adverse events
Determine the toxicity profile the 4SCAR-276-modified T cells with Common Toxicity Criteria for Adverse Effects version 4.0
Time frame
3 yearsSecondary outcomes
1
Anti-tumor effects
Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on imaging analysis.
Time frame
1 year2
Survival time of the patients
Evaluate the survival time of the patients treated with the 4SCAR-276 T cells, including progression free survival (PFS) and overall survival (OS).
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: