NCT05437328

GD2/CD56 Bi-specific CAR-T Cell Therapy

Recruiting now Phase 1, PHASE2 Last updated 29 June 2022

What this trial tests

Phase 1, PHASE2 trial testing bi-4SCAR GD2/CD56 T cells in Malignant Disease in 60 participants. Currently enrolling.

Timeline

30 June 2022

Primary endpoint
31 December 2025

30 June 2026

Quick facts

Lead sponsor	Shenzhen Geno-Immune Medical Institute
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	30 June 2022
Primary completion	31 December 2025
Estimated completion	30 June 2026
Sites	1 location across China

Drugs / interventions tested

• bi-4SCAR GD2/CD56 T cells — full drug profile →

Conditions studied

• Malignant Disease — all drugs for Malignant Disease →

Sponsor

Shenzhen Geno-Immune Medical Institute

Who can join

Adults 1 to 75, any sex, with Malignant Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. GD2-targeting therapy: a comparative analysis of approaches and promising directions.
   Philippova J, Shevchenko J, Sennikov S. · · 2024 · cited 25× · PMID 38558810 · DOI 10.3389/fimmu.2024.1371345
2. CAR Based Immunotherapy of Solid Tumours-A Clinically Based Review of Target Antigens.
   Maher J, Davies DM. · · 2023 · cited 13× · PMID 36829563 · DOI 10.3390/biology12020287
3. Smaller size packs a stronger punch - Recent advances in small antibody fragments targeting tumour-associated carbohydrate antigens.
   Khilji SK, Op 't Hoog C, Warschkau D, Lühle J, et al · · 2023 · cited 9× · PMID 37284439 · DOI 10.7150/thno.80901
4. Current Indications and Future Landscape of Bispecific Antibodies for the Treatment of Lung Cancer.
   Arasanz H, Chocarro L, Fernández-Rubio L, Blanco E, et al · · 2023 · cited 6× · PMID 37373003 · DOI 10.3390/ijms24129855
5. Expanding the frontier of CAR therapy: comparative insights into CAR-T, CAR-NK, CAR-M, and CAR-DC approaches.
   Zhang Y, Hu R, Xie X, Li Y. · · 2025 · cited 4× · PMID 40928667 · DOI 10.1007/s00277-025-06538-0
6. CAR-T therapy for endocrine neoplasms: novel targets and combination of therapies.
   Wang F, Zhang R, Zhou Z, Shi R, et al · · 2025 · cited 2× · PMID 40007813 · DOI 10.3389/fendo.2025.1517525
7. Decoding signaling architectures: CAR versus TCR dynamics in solid tumor immunotherapy.
   Chen Z, Zhou X. · · 2026 · cited 1× · PMID 41132090 · DOI 10.3724/abbs.2025190
8. CAR-T Therapy Beyond B-Cell Hematological Malignancies.
   Canichella M, de Fabritiis P. · · 2025 · cited 1× · PMID 39791742 · DOI 10.3390/cells14010041