NCT07419880

Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer

RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer

Detailed description

This is a phase II, open-Label, single-arm, multicenter clinical trial investigating the efficacy and safety of cromolyn for potentiating ADC combined with immunotherapy in refractory triple-negative breast cancer. Based on previous findings, the infiltration level of antigen-presenting mast cells (apMCs) was significantly correlated with clinical benefits from immunotherapy. Cromolyn, a mast cell membrane stabilizer, demonstrated promising efficacy in the phase II "Renaissance" clinical study. Among 10 patients with anti-PD-1/PD-L1-resistant TNBC, the combination of cromolyn with chemotherapy and immunotherapy achieved an objective response rate (ORR) of 50%. To further validate these findings, we have designed this study to enroll TNBC patients who have progressed after conventional treatments (including chemotherapy, immunotherapy, ADC, etc.), with the aim of further investigating the synergistic effects of cromolyn sodium combined with ADC and PD-1 monoclonal antibody against refractory TNBC tumors at the clinical level.

Conditions

• Triple -Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Cromolyn, TQB2102, and Panpulimab	Upon enrollment, patients will receive intravenous administration of penpulimab (200 mg) and TQB2102 (6 mg/kg) every three weeks, along with intranasal delivery of cromolyn sodium (each dose 10 mg \[5 sprays per nostril, bilaterally\], four times daily, administered 30 minutes before meals and at bedtime).

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-01-30
• Completion: 2027-04-30
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: China