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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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).
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Objective Response Rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease Control Rate(DCR)
Complete remission or partial remission or stable disease (according to RECIST1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression Free Survival(PFS)
Time to progressive disease (according to RECIST1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Time to death due to any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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