GD2/CD56 Bi-specific CAR-T Cell Therapy

NCT05437328 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-22006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Disease

Keywords

CAR-T; cancer; GD2; CD56

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events.

  Determine the toxicity profile the bi-4SCAR GD2/CD56 cells with Common Toxicity Criteria for Adverse Effects version 4.0

  6 months

Secondary Outcomes (6)

• Anti-tumor effects

  1 year

• Anti-tumor effects

  1 year

• The expansion of bi-4SCAR GD2/CD56 T cells

  1 year

• The persistence of bi-4SCAR GD2/CD56 T cells

  1 year

• Survival time of the patients

  3 years

Study Arms (1)

bi-4SCAR-GD2/CD56 T Cell Therapy for GD2 and/or CD56 positive tumor

EXPERIMENTAL

Biological: bi-4SCAR GD2/CD56 T cells

Interventions

bi-4SCAR GD2/CD56 T cells BIOLOGICAL

Infusion of bi-4SCAR GD2/CD56 T cells at 10\^6 cells/kg body weight via IV

bi-4SCAR-GD2/CD56 T Cell Therapy for GD2 and/or CD56 positive tumor

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-0755-86725195; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 29, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)