NCT06640582: BAH2472

TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas

Recruiting now Phase 1, PHASE2 Last updated 5 November 2024

What this trial tests

Phase 1, PHASE2 trial testing Tumor Infiltrating Lymphocytes (TIL) in Brain Tumor in 85 participants. Currently enrolling.

Timeline

20 October 2024

Primary endpoint
10 September 2026

28 December 2026

Quick facts

Lead sponsor	Essen Biotech
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	20 October 2024
Primary completion	10 September 2026
Estimated completion	28 December 2026
Sites	1 location across China

Drugs / interventions tested

• Tumor Infiltrating Lymphocytes (TIL)
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Interleukin-2
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Brain Tumor — all drugs for Brain Tumor →
• Brain Metastases — all drugs for Brain Metastases →
• Brain Cancer — all drugs for Brain Cancer →
• Glioma — all drugs for Glioma →

Sponsor

Essen Biotech — full company profile →

Who can join

Adults 16 to 90, any sex, with Brain Tumor or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and Meningiomas . Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to Brain cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

Publications & conference data

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

1. Current trends in sensitizing immune checkpoint inhibitors for cancer treatment.
   Wei J, Li W, Zhang P, Guo F, et al · · 2024 · cited 82× · PMID 39725966 · DOI 10.1186/s12943-024-02179-5
2. Emerging insights into the immunosuppressive tumor microenvironment and its implications for glioblastoma immunotherapy.
   Nicolaou N, Andreou MS, Neophytou CM, Papageorgis P. · · 2025 · cited 2× · PMID 41208963 · DOI 10.3389/fimmu.2025.1665742
3. Optic Pathway Glioma: Current Treatment Approaches and Ongoing Clinical Trials.
   Elzaafarany O, Elhomosany S, Rincones A, Dlugi V, et al · · 2025 · cited 2× · PMID 40867225 · DOI 10.3390/brainsci15080894
4. Tumor-infiltrating T Lymphocytes Recognize Thyroid-specific Proteins and Neo-antigens in Follicular Cell-derived Thyroid Cancers.
   Garza B, Calhoun J, Norman PJ, Cline N, et al · · 2026 · cited 1× · PMID 41275380 · DOI 10.1210/clinem/dgaf639
5. Opportunities to Modulate Tumor Ecosystem Toward Successful Glioblastoma Immunotherapy.
   Takahashi M, Mukhamejanova D, Jasewicz H, Acharya N, et al · · 2025 · cited 1× · PMID 40123277 · DOI 10.1111/cas.70052
6. Current Status and Evolution of Immunotherapy in Glioma Management.
   Liu J, Yang G, Cao Z, Qin H, et al · · 2026 · PMID 42158823 · DOI 10.7150/ijms.132708
7. Adoptive Cell Therapies for Glioblastoma: A Quest for Cures from Within.
   Leu JS, Ge X, Yu CR, Peng G, et al · · 2026 · PMID 42041891 · DOI 10.3390/biology15080614
8. Immune Exhaustion in Chronic Infection and Cancer: Signaling Pathways and Therapeutic Interventions.
   Song Y, Mo Y, Chen S, Chen Y, et al · · 2026 · PMID 41768369 · DOI 10.1002/mco2.70635