Autologous TIL Therapy + Pembrolizumab + IL-2 for Advanced Refractory Breast Cancer
This Phase I/II study at District One Hospital, Beijing evaluates autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) for patients with advanced or metastatic breast cancer — including triple-negative breast cancer — who have exhausted standard treatment options. CancerFax helps international patients organize records and access the trial team.
About This Clinical Trial
Advanced or metastatic breast cancer that has progressed after standard lines of treatment represents one of the most urgent unmet needs in oncology. Patients with hormone receptor-positive disease that has become endocrine-resistant, HER2-positive disease that has progressed after HER2-targeted agents, and especially those with triple-negative breast cancer (TNBC) — which lacks ER, PR, and HER2 expression and responds poorly to many available therapies — face limited options and significant clinical pressure to find new treatment pathways.
This Phase I/II trial (BAH249), sponsored by Essen Biotech and conducted at District One Hospital in Beijing, evaluates autologous tumor-infiltrating lymphocyte (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) in patients with advanced or metastatic refractory breast cancer. TILs are T lymphocytes naturally found within the tumor microenvironment that have been exposed to tumor antigens. They are extracted from a patient biopsy, expanded in a specialized GMP laboratory to large numbers, and reinfused after the patient undergoes preparative lymphodepletion with cyclophosphamide and fludarabine. Pembrolizumab (a PD-1 checkpoint inhibitor) is added to sustain and enhance T cell activity, while IL-2 supports TIL survival and proliferation in vivo.
Breast cancer — particularly TNBC — is scientifically well-suited to immunotherapy exploration. TNBC tumors typically carry higher tumor mutational burden (TMB) and greater TIL infiltration at baseline compared to hormone receptor-positive subtypes, making them more immunogenic. TILs extracted from breast tumors are already reactive against the patient's own cancer antigens, offering a polyclonal immune response that may address tumor heterogeneity more effectively than single-antigen targeted approaches. PD-1 blockade with Pembrolizumab is already approved for PD-L1-positive metastatic TNBC, and combining it with expanded autologous TILs is a scientifically grounded strategy to amplify this immune response.
Essen Biotech is running a coordinated TIL therapy program across multiple solid tumor types including colorectal, lung, gastric, and breast cancers — all at District One Hospital under consistent protocols. This BAH249 study is specifically designed to characterize safety and generate the initial efficacy signal for TIL therapy in breast cancer, with response assessed by RECIST v1.1 criteria and follow-up extending to 36 months.
CancerFax can help organize your pathology, imaging, and treatment history into a structured case summary and facilitate communication with the trial team at District One Hospital in Beijing. We do not enroll patients directly — we help patients and families navigate the process.
Trial at a Glance
A summary of the key details for this Phase I/II study, drawn from the official ClinicalTrials.gov registry entry for NCT06532812.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
This trial uses autologous tumor-infiltrating lymphocyte (TIL) therapy — a personalized form of adoptive cell therapy in which the patient's own T cells, extracted from inside their breast tumor, are expanded to billions of cells in a GMP laboratory and returned to the body to fight the cancer. Unlike engineered CAR-T cells, TILs carry a natural, polyclonal repertoire of T cell receptors already directed against the patient's tumor antigens.
TIL therapy is combined with Pembrolizumab (Keytruda), a PD-1 checkpoint inhibitor that prevents T cells from being silenced by the tumor's immune-suppressive signals, and with Aldesleukin (Interleukin-2, IL-2), which provides a proliferation and survival signal to keep infused TILs active in the body. Before the TIL infusion, a non-myeloablative lymphodepletion regimen using cyclophosphamide and fludarabine is administered to create immunological space for the expanded T cells.
The complete treatment process involves multiple steps spanning several weeks and requires inpatient hospital admission at District One Hospital, Beijing. International patients should plan for an extended stay during the manufacturing and treatment phases.
How the therapy works (in simple terms)
How it is given
A tumor tissue sample is collected — via core needle biopsy, surgical excision, or accessible metastatic lesion — to harvest tumor-infiltrating lymphocytes. At least one accessible tumor lesion or source of malignant body fluid is required.
The harvested TILs are transported to a specialized GMP facility where they are stimulated with growth factors and expanded over several weeks. The goal is to produce billions of tumor-reactive T cells ready for infusion.
Before TIL infusion, the patient is admitted and receives cyclophosphamide and fludarabine for approximately 5–7 days. This non-myeloablative regimen depletes the patient's existing T cell population, creating favorable conditions for the incoming TILs to engraft and expand.
The expanded, autologous TILs are infused intravenously in a single infusion session. This is the central treatment event and is performed under close clinical monitoring as an inpatient at the trial site.
Following TIL infusion, Aldesleukin (IL-2) is administered to support TIL survival and proliferation in the body. Pembrolizumab (Keytruda) is also given to block the PD-1 checkpoint, preventing tumor-mediated suppression of the infused T cells.
Patients undergo regular clinical assessments, lab tests, and imaging (RECIST v1.1) during and after treatment. Follow-up continues for up to 36 months. CancerFax can assist with logistics for follow-up visits for international patients.
Primary endpoint: Safety — incidence and severity of adverse events assessed over 6 months. Secondary endpoints (assessed up to 36 months by RECIST v1.1): Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), and Quality of Life (QoL).
Who This Trial May Be For
This trial is specifically designed for patients with advanced or metastatic breast cancer who have not responded to or have relapsed after standard therapy. The following patient profiles reflect those most likely to meet eligibility criteria.
You have a histologically confirmed diagnosis of breast cancer — including hormone receptor-positive (HR+), HER2-positive, or triple-negative breast cancer (TNBC) — that is locally advanced, recurrent, or metastatic. All subtypes are eligible as there is no biomarker prerequisite.
You have failed at least one standard treatment regimen for your breast cancer subtype, or no standard options remain. This typically includes patients who have progressed on chemotherapy, endocrine therapy, CDK4/6 inhibitors, HER2-targeted agents, or prior checkpoint inhibitors.
You have a tumor region accessible for biopsy or resection — or a source of malignant body fluid — from which tumor-infiltrating lymphocytes can be isolated. This is a prerequisite for the TIL manufacturing process.
You have a Karnofsky score of ≥60% or an ECOG performance status of 0–2, indicating you are well enough to tolerate the TIL manufacturing period, lymphodepletion regimen, and TIL infusion with post-infusion support therapy.
Your blood counts, liver enzymes, kidney function, and cardiac parameters meet the protocol thresholds (e.g., ANC ≥1.5×10⁹/L, hemoglobin ≥90 g/L, creatinine ≤1.5 mg/dL, ALT/AST ≤3×ULN). Lab work must be completed within 7 days of enrollment.
International patients must be prepared to travel to District One Hospital in Beijing for tumor biopsy, formal screening, lymphodepletion, TIL infusion, and follow-up visits. CancerFax provides logistics, visa, interpreter, and accommodation planning support.
Eligibility Criteria
The following criteria are reproduced from the official ClinicalTrials.gov registry entry for NCT06532812. They are provided to help patients understand whether to pursue a formal eligibility review. Only the trial investigators can make a final determination.
check_circleInclusion Criteria — May Be Eligible
- ✓Age 16 to 90 years
- ✓Histologically confirmed primary, relapsed, or metastatic breast cancer
- ✓Expected life span of more than 3 months
- ✓Karnofsky ≥60% or ECOG performance status 0–2
- ✓Failed standard treatment regimens, or no standard regimens are available
- ✓Has tumor region(s) eligible for biopsy or resection, or malignant body fluid from which TILs can be isolated
- ✓At least 1 evaluable tumor lesion per RECIST v1.1
- ✓Adequate hematology within 7 days prior to enrollment: WBC ≥2.5×10⁹/L, ANC ≥1.5×10⁹/L, lymphocytes ≥0.7×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L
- ✓APTT ≤1.5×ULN; INR ≤1.5×ULN (unless on anticoagulant therapy in prior 3 days)
- ✓Serum creatinine ≤1.5 mg/dL (or ≤132.6 μmol/L), or creatinine clearance ≥50 mL/min
- ✓Serum ALT/AST ≤3×ULN (≤3×ULN for liver metastasis); total bilirubin ≤1.5×ULN
- ✓No absolute or relative contraindications to biopsy or surgical procedure
- ✓Patients of childbearing potential must use approved highly effective contraception from consent through 1 year after completion of lymphodepletion
- ✓All prior anti-tumor therapies (radiotherapy, chemotherapy, biologics) must have ceased at least 28 days before TIL harvest
- ✓Able to understand and sign the informed consent document
- ✓Able to adhere to follow-up visit plan and study requirements
cancelExclusion Criteria — May Not Be Eligible
- ×Requires systemic glucocorticoid treatment at prednisone >15 mg/day (or equivalent), or has autoimmune diseases requiring immunomodulatory treatment
- ×FEV1 <2L or DLCO (calibrated) <40%
- ×Significant cardiovascular disease: NYHA Grade III–IV congestive heart failure, clinically significant low blood pressure, uncontrolled coronary artery disease, ejection fraction <35%, or severe arrhythmias (ventricular arrhythmia requiring clinical intervention, second- or third-degree AV block)
- ×HIV infection or positive anti-HIV antibody; active HBV or HCV infection (HBsAg positive and/or anti-HCV positive); syphilis infection or positive Treponema pallidum antibody
- ×Severe physical or mental disease
- ×Active systemic infection requiring treatment, or positive blood cultures or imaging evidence of infection
- ×Received or currently receiving other investigational medicines, biologic therapy, chemotherapy, or radiotherapy within 1 month
- ×History of allergy to chemical or biological substances similar in composition to cell therapy products
- ×Prior immunotherapy resulting in irAE of Grade 3 or higher
- ×Prior anti-tumor treatment AEs that have not recovered to CTCAE 5.0 Grade 1 or below (except alopecia or other non-safety-relevant toxicities)
- ×Pregnancy or lactation
- ×History of organ transplantation, allogeneic stem cell transplantation, or renal replacement therapy
- ×Any other severe systemic disease or reason deemed by investigators to make the subject inappropriate for study participation
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
To support an eligibility pre-assessment, CancerFax recommends preparing the following documents. Having them ready allows our team to produce a structured case summary for the trial center in Beijing.
How the Trial Process May Work
From first contact to follow-up, the TIL therapy trial process involves multiple stages over several weeks to months. CancerFax guides patients through each step.
Contact CancerFax. Our team will collect your medical records — pathology, imaging, and treatment history — and organize them into a structured medical summary for eligibility pre-assessment.
Your case is mapped against the published trial criteria. CancerFax shares a candid assessment and, if appropriate, initiates communication with the trial coordination team at District One Hospital.
If the trial team expresses interest, CancerFax facilitates the formal referral and helps arrange a screening consultation in Beijing — including scheduling and pre-visit logistics.
You travel to District One Hospital for formal screening — including laboratory tests, imaging review, biopsy assessment, and the informed consent process. Investigators make the final eligibility determination.
Tumor tissue is collected for TIL expansion. The manufacturing phase takes several weeks. You then return for lymphodepletion, TIL infusion, and inpatient administration of IL-2 and Pembrolizumab under close medical supervision.
Tumor response is assessed by RECIST v1.1 imaging at defined intervals. Safety monitoring continues throughout. Follow-up visits extend for up to 36 months. CancerFax assists with logistics for return visits.
Potential Benefits
Joining a clinical trial may offer access to treatments not otherwise available. The following potential benefits are relevant to this TIL therapy study for breast cancer.
Autologous TIL therapy is not commercially approved for breast cancer. This trial provides access to a highly personalized adoptive cell therapy — manufactured from the patient's own tumor — that is otherwise unavailable outside of clinical research.
The combination of TIL cells, PD-1 blockade (Pembrolizumab), and IL-2 is designed to deliver a layered immune attack: infusing reactive T cells, sustaining them with growth factor support, and removing checkpoint-mediated suppression simultaneously.
This trial is designed specifically for patients who have exhausted approved therapies — including chemotherapy, endocrine agents, HER2-targeted drugs, and prior immunotherapy — offering a scientifically supported pathway when conventional options are no longer working.
Triple-negative breast cancer, which has limited targeted therapy options, may be particularly relevant for TIL therapy given its typically higher tumor immunogenicity. This trial is open to TNBC patients alongside other breast cancer subtypes.
Participants receive close clinical attention throughout treatment and structured follow-up — a level of care that may provide broader health management benefits beyond the study's primary immunotherapy objectives.
Clinical trials study whether new treatments work. Individual responses vary significantly. CancerFax does not promise a clinical response, remission, or cure.
Risks and Side Effects
TIL therapy combined with Pembrolizumab and IL-2 involves a complex treatment process with a range of known and potential adverse effects. The trial's primary endpoint is safety characterization — patients are closely monitored throughout.
Patients may experience fever, chills, rigors, hypotension, or allergic-type reactions during or following TIL infusion. Inpatient monitoring is provided at the time of and after infusion.
Cyclophosphamide and fludarabine suppress bone marrow function and the immune system, increasing the risk of serious infection, neutropenic fever, anaemia, and bleeding during the preparatory phase. Supportive care including growth factors and antibiotics is provided.
IL-2 can cause capillary leak syndrome, systemic hypotension, fluid retention, pulmonary oedema, renal impairment, and cardiac arrhythmias. IL-2 dosing and schedule are carefully managed by the inpatient clinical team.
Pembrolizumab can trigger immune-mediated inflammation in any organ — including pneumonitis, colitis, hepatitis, nephritis, rash, and endocrinopathies (thyroid, adrenal, pituitary). Most irAEs are manageable with corticosteroids but may require permanent discontinuation of Pembrolizumab.
Following lymphodepletion, patients are transiently profoundly immunocompromised and at elevated risk of bacterial, viral, and fungal infections including sepsis. Prophylactic antimicrobials and close inpatient monitoring are standard protocol management.
Most patients experience fatigue, nausea, vomiting, and flu-like symptoms from both lymphodepletion chemotherapy and systemic immunotherapy. These are expected and managed with supportive care.
In some cases, the tumor sample may not yield sufficient viable TILs for laboratory expansion. If manufacturing fails, the patient cannot proceed with this specific treatment. The trial team will discuss alternative options in this scenario.
This list is not exhaustive. Trial investigators will explain all known and potential risks in full during the informed consent process. CancerFax does not provide medical advice on individual treatment decisions.
Trial Location and Hospital Information
This trial is conducted at a single center — District One Hospital in Beijing, China. The hospital is the clinical site for Essen Biotech's TIL therapy program across multiple tumor types. International patients will need to plan travel to Beijing for tumor biopsy, screening, lymphodepletion, TIL infusion, and follow-up visits. CancerFax provides comprehensive logistics and coordination support for patients traveling from outside China.
The trial site accepts international patients. CancerFax can assist with medical visa applications, airport-to-hospital coordination, interpreter services for consultations and consent, accommodation near the trial site, and ongoing communication with the trial team in English. We recommend reaching out early, as TIL therapy logistics require significant advance planning — particularly for the manufacturing and treatment phases.
Costs, Trial Coverage, and Patient Expenses
Clinical trials typically reduce the financial burden of investigational therapy, but not all associated costs are covered. The table below reflects standard coverage patterns for Phase I/II cell therapy trials in China. Always confirm coverage details directly with Essen Biotech and District One Hospital before committing to participation.
Coverage details should be verified directly with Essen Biotech and the trial coordinator at District One Hospital before enrollment. Individual circumstances and protocol amendments may affect what is covered.
Standard Treatment vs Clinical Trial
For patients with advanced refractory breast cancer who have exhausted standard lines of therapy, this comparison illustrates how trial participation may differ from continuing palliative or supportive care.
How CancerFax Can Help
Accessing a specialized TIL therapy trial in Beijing involves multiple clinical, logistical, and language challenges. CancerFax provides end-to-end navigation support so patients and families can focus on the care — not the coordination.
Our oncology navigation team reviews your pathology, imaging, and treatment history and organizes everything into a structured case summary tailored to the eligibility criteria of this trial.
We map your clinical profile against the published inclusion and exclusion criteria and provide an honest, realistic assessment of whether formal screening at the trial site is appropriate for your case.
CancerFax communicates directly with the trial coordination team at District One Hospital in Beijing — in English and Mandarin — to facilitate the formal referral and arrange a screening appointment.
We provide practical guidance on medical visa applications, airport-to-hospital coordination, accommodation near the trial site, and planning for extended stays during the TIL manufacturing and treatment phases.
Our team provides interpreter support for medical consultations and helps translate critical documents and consent materials — ensuring clear communication between patients and their clinical team in Beijing.
From first inquiry through treatment and long-term follow-up, CancerFax remains a dedicated point of contact — coordinating logistics, managing communication, and supporting patients and families throughout this complex process.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
Before agreeing to participate, it is important to have a clear conversation with the trial investigators. The following questions are a practical starting point.
Frequently Asked Questions
Ready to Explore This Trial?
If you or a loved one has been diagnosed with advanced or metastatic breast cancer — including triple-negative breast cancer — and standard treatments are no longer working, this TIL therapy trial may represent a meaningful pathway worth exploring. CancerFax will help you assess whether your case may be suitable, organize your records, and facilitate access to the trial team in Beijing.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
Related Resources on CancerFax
© CancerFax · Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.