NCT04432649

Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276

Status unknown Phase 1, PHASE2 Last updated 16 June 2020

What this trial tests

Phase 1, PHASE2 trial testing 4SCAR-276 in Solid Tumor in 100 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
31 May 2023

31 May 2024

Quick facts

Lead sponsor	Shenzhen Geno-Immune Medical Institute
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 June 2020
Primary completion	31 May 2023
Estimated completion	31 May 2024
Sites	3 locations across China

Drugs / interventions tested

• 4SCAR-276 — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →

Sponsor

Shenzhen Geno-Immune Medical Institute

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

1. B7-H3: An Attractive Target for Antibody-based Immunotherapy.
   Kontos F, Michelakos T, Kurokawa T, Sadagopan A, et al · · 2021 · cited 311× · PMID 33051306 · DOI 10.1158/1078-0432.ccr-20-2584
2. CAR T Cell Therapy for Solid Tumors: Bright Future or Dark Reality?
   Wagner J, Wickman E, DeRenzo C, Gottschalk S. · · 2020 · cited 284× · PMID 32979309 · DOI 10.1016/j.ymthe.2020.09.015
3. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
4. Immune checkpoint of B7-H3 in cancer: from immunology to clinical immunotherapy.
   Zhao B, Li H, Xia Y, Wang Y, et al · · 2022 · cited 145× · PMID 36284349 · DOI 10.1186/s13045-022-01364-7
5. Clinical Insights Into Novel Immune Checkpoint Inhibitors.
   Lee JB, Ha SJ, Kim HR. · · 2021 · cited 81× · PMID 34025438 · DOI 10.3389/fphar.2021.681320
6. Recent developments in immunotherapy for gastrointestinal tract cancers.
   Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x
7. B7-H3 Inhibitors in Oncology Clinical Trials: A Review.
   Feustel K, Martin J, Falchook GS. · · 2024 · cited 45× · PMID 38327753 · DOI 10.36401/jipo-23-18
8. Targeting the immune checkpoint B7-H3 for next-generation cancer immunotherapy.
   Liu C, Zhang G, Xiang K, Kim Y, et al · · 2022 · cited 31× · PMID 34739560 · DOI 10.1007/s00262-021-03097-x