Triple -Negative Breast CancerPhase 2RECLAIMNCT07419880
Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer
A Phase 2 study testing Cromolyn, TQB2102, and Panpulimab in people with Triple -Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple -Negative Breast Cancer
- What is being tested?
- Cromolyn, TQB2102, and Panpulimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Female, ≥18 years old and ≤70 years old.
- Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with <1% positive tumor cells; PR-negative with <1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH/CISH without amplification).
- Prior Treatment: Recurrent or metastatic refractory breast cancer with disease progression after prior immunotherapy.
- Measurable Disease: At least one measurable lesion per RECIST v1.1 (≥20 mm by conventional CT or ≥10 mm by spiral CT; lesion must not have been previously irradiated).
- Organ Function: Adequate organ function as follows:
- Blood Counts: Hemoglobin ≥90 g/L (no transfusion within 14 days); absolute neutrophil count ≥1.5×10⁹/L; platelets ≥75×10⁹/L.
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- Blood Chemistry: Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN (≤5×ULN if liver metastases are present); serum creatinine ≤1×ULN; creatinine clearance >50 mL/min (Cockcroft-Gault formula).
- Treatment-Free Interval: No radiotherapy, endocrine therapy, molecular targeted therapy, or major surgery within 3 weeks prior to study entry; recovery from prior treatment-related toxicities (surgical wounds fully healed if applicable); absence of peripheral neuropathy or only grade I peripheral neuropathy.
- Performance Status: ECOG performance status ≤1, and life expectancy ≥3 months.
- Contraception: Women of childbearing potential must agree to use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
- Consent: Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).
- CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.
- Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
- Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.
- Recent Major Surgery: Undergone major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment.
- Pregnancy or Lactation: Patients who are pregnant or breastfeeding.
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- Other Malignancies: History of other malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Impaired Drug Absorption: Conditions affecting oral drug intake and absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction.
- Uncontrolled Effusions: Uncontrolled third-space effusions (e.g., significant pleural or ascitic fluid) not manageable by drainage or other methods.
- Non-Healing Conditions: Long-term non-healing wounds or incompletely healed fractures.
- Active Viral Hepatitis: Active HBV or HCV infection (HBV-DNA ≥ 500 IU/mL) or chronic hepatitis with abnormal liver function.
- Allergic History: Known allergy or hypersensitivity to any component of the study regimen, or history of hypersensitivity to other monoclonal antibodies.
- Eosinophilia/Mastocytosis: Patients with eosinophilia or mastocytosis.
- Steroid Use: Chronic use of oral corticosteroids. Occasional past use requires a 4-week washout period before enrollment.
- Prior Use of Specific Therapies: Previous treatment with PD-1/TGF-β bispecific antibody, PD-1/CTLA-4 bispecific antibody, PD-1/VEGF bispecific antibody, or anti-HER2 dual-epitope ADC; or use of ADC agents in ≥2 prior lines of therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, +88807 08664175590, zhimingshao@yahoo.com
About this study
Official title: RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer
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
Read the 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
- Being tested
- Cromolyn, TQB2102, and Panpulimab
- Keywords
- TNBC, Molecular Subtype, Precision Treatment, Immunotherapy, Cromolyn, Antibody-Drug Conjugate
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cromolyn, TQB2102, and PanpulimabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Cromolyn plus TQB2102and Panpulimab | Experimental | Cromolyn：a mast cell membrane stabilizer；TQB2102: HER2-ADC； Panpulimab: anti PD-1 Receives: Drug: Cromolyn, TQB2102, and Panpulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: 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
Secondary outcomes (3)
Disease Control Rate(DCR)
Complete remission or partial remission or stable disease (according to RECIST1.1)
Measured: 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)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple -Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419880
- Sponsor's protocol ID
- SCHBCC-N0106
- Acronym
- RECLAIM
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07419880
- Acronym / sponsor ID
- RECLAIM / SCHBCC-N0106
- Conditions
- Triple -Negative Breast Cancer
- Keywords
- TNBC, Molecular Subtype, Precision Treatment, Immunotherapy, Cromolyn, Antibody-Drug Conjugate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cromolyn plus TQB2102and Panpulimab | Experimental | Drug: Cromolyn, TQB2102, and PanpulimabCromolyn：a mast cell membrane stabilizer；TQB2102: HER2-ADC； Panpulimab: anti PD-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: Female, ≥18 years old and ≤70 years old.
- Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with <1% positive tumor cells; PR-negative with <1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH/CISH without amplification).
- Prior Treatment: Recurrent or metastatic refractory breast cancer with disease progression after prior immunotherapy.
- Measurable Disease: At least one measurable lesion per RECIST v1.1 (≥20 mm by conventional CT or ≥10 mm by spiral CT; lesion must not have been previously irradiated).
- Organ Function: Adequate organ function as follows:
Key exclusion criteria (15 listed)
- Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).
- CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.
- Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
- Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.
- Recent Major Surgery: Undergone major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cromolyn, TQB2102, and PanpulimabUpon 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). | Drug | Cromolyn plus TQB2102and Panpulimab |
Primary outcome
Objective Response Rate (ORR)
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
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
3 secondary outcomes
Disease Control Rate(DCR)
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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhimin Shao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cromolyn, TQB2102, and Panpulimab in people with Triple -Negative Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao (+88807 08664175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.