GD2/CD56 Bi-specific CAR-T Cell Therapy

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    60
  • sponsor
    Shenzhen Geno-Immune Medical Institute
Updated on 14 July 2022

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/CD56 bi-specific CAR-T cell therapy in patients with GD2 and/or CD56 positive cancer. Another goal of the study is to learn more about the function of the anti-GD2/CD56 bi-specific CAR-T cells and their persistency in patients.

Description

Patients with refractory and/or recurrent malignancies have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators attempt to use T cells genetically modified to express a 4th generation lentiviral GD2/CD56 bi-specific chimeric antigen receptor (bi-4SCAR-GD2/CD56). The chimeric antigen receptor (CAR) molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, GD2 or CD56, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.

Disialoganglioside (GD2) is a well-studied tumor associated antigen which is expressed uniformly in nervous system-related tumors but at low levels in normal tissues. Over the past few years, CAR-T therapy against GD2 in tumor has achieved encouraging but modest outcomes. Only a fraction of patients achieved measurable responses. In solid tumors, GD2 CAR-T therapy alone may not be as effective as CAR-T cell therapy in hematological malignancies.

Similar to GD2, the CD56 antigen (NCAM-1) is highly expressed on malignancies with neuronal or neuroendocrine differentiation, including small-cell lung cancer, glioblastoma and neuroblastoma, tumor types for which new therapeutic options are needed. CD56-CAR-T cell therapy has potential for treating patients with aggressive malignancies that are nonresponsive to conventional radiotherapy and chemotherapy, or are unsuitable for hematopoietic stem cell transplantation.

To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific GD2/CD56 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in GD2 and/or CD56 positive cancer patients.

Details
Condition Malignant Disease
Treatment bi-4SCAR GD2/CD56 T cells
Clinical Study IdentifierNCT05437328
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with tumors received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent
The expression status of GD2 or CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 antibody staining results based on immunohistochemistry or flow cytometry analyses
Body weight greater than or equal to 10 kg
Age: ≥1 year and ≤ 75 years of age at the time of enrollment
Life expectancy: at least 8 weeks
Prior Therapy
There is no limit to the number of prior treatment regimens. Any grade 3 or 4
non-hematologic toxicity of any previous therapy must be resolved to grade 2
or less
Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection
At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen
At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody
At least 1 week since any radiation therapy at the time of study entry
Karnofsky/jansky score of 60% or greater
Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent
Pulse Ox greater than or equal to 90% on room air
Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN
Renal function: Patients must have serum creatinine less than 3 times upper limit of normal
Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion)
Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity
For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent

Exclusion Criteria

Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity
Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible
Previous treatment with other genetically engineered GD2 or CD56-specific CAR T cells
Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection
Patients who require systemic corticosteroid or other immunosuppressive therapy
Evidence of tumor potentially causing airway obstruction
Inability to comply with protocol requirements
Insufficient CAR T cells availability
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