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Trial record 1 of 1 for:    NCT05437328
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GD2/CD56 Bi-specific CAR-T Cell Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05437328
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Disease Biological: bi-4SCAR GD2/CD56 T cells Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GD2/CD56 Bi-specific CAR-T Cells for Cancer Treatment
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: bi-4SCAR-GD2/CD56 T Cell Therapy for GD2 and/or CD56 positive tumor Biological: bi-4SCAR GD2/CD56 T cells
Infusion of bi-4SCAR GD2/CD56 T cells at 10^6 cells/kg body weight via IV

Primary Outcome Measures :
  1. Number of patients with adverse events. [ Time Frame: 6 months ]
    Determine the toxicity profile the bi-4SCAR GD2/CD56 cells with Common Toxicity Criteria for Adverse Effects version 4.0

Secondary Outcome Measures :
  1. Anti-tumor effects [ Time Frame: 1 year ]
    Objective complete response (CR) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

  2. Anti-tumor effects [ Time Frame: 1 year ]
    Objective partial response (PR) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

  3. The expansion of bi-4SCAR GD2/CD56 T cells [ Time Frame: 1 year ]
    Scale of CAR copies

  4. The persistence of bi-4SCAR GD2/CD56 T cells [ Time Frame: 1 year ]
    Scale of tumor burden (for efficacy)

  5. Survival time of the patients [ Time Frame: 3 years ]
    The progression free survival (PFS) time of the patients treated with the bi-4SCAR GD2/CD56 T cells will be evaluated

  6. Survival time of the patients [ Time Frame: 3 years ]
    The overall survival (OS) time of the patients treated with the bi-4SCAR GD2/CD56 T cells will be evaluated

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with tumors received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
  2. 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.
  3. Body weight greater than or equal to 10 kg.
  4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
  5. Life expectancy: at least 8 weeks.
  6. 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.

  7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.
  8. 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.
  9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.
  10. At least 1 week since any radiation therapy at the time of study entry.
  11. Karnofsky/jansky score of 60% or greater.
  12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent.
  13. Pulse Ox greater than or equal to 90% on room air.
  14. 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.
  15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.
  16. 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).
  17. 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.
  18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.

Exclusion Criteria:

  1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.
  2. 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.
  3. Previous treatment with other genetically engineered GD2 or CD56-specific CAR T cells.
  4. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection.
  5. Patients who require systemic corticosteroid or other immunosuppressive therapy.
  6. Evidence of tumor potentially causing airway obstruction.
  7. Inability to comply with protocol requirements.
  8. Insufficient CAR T cells availability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05437328

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Contact: Lung-Ji Chang, PhD 86-0755-86725195

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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-0755-86725195   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
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Responsible Party: Shenzhen Geno-Immune Medical Institute Identifier: NCT05437328    
Other Study ID Numbers: GIMI-IRB-22006
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen Geno-Immune Medical Institute: