Autologous TIL Therapy + Pembrolizumab + IL-2 for Advanced Refractory Colorectal Cancer
This Phase I/II study at District One Hospital, Beijing evaluates autologous tumor-infiltrating lymphocytes (TIL) combined with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) for patients with advanced or metastatic colorectal cancer who have failed standard treatments. CancerFax can help organize your records and coordinate eligibility review with the trial team.
About This Clinical Trial
Advanced or metastatic colorectal cancer (CRC) that has progressed after standard lines of treatment — including FOLFOX, FOLFIRI, bevacizumab, cetuximab, and checkpoint inhibitors — represents one of oncology's most difficult clinical challenges. Patients in this setting face limited options, poor prognoses, and a critical unmet need for new, effective therapies capable of generating durable responses.
This Phase I/II trial, sponsored by Essen Biotech and conducted at District One Hospital in Beijing, evaluates autologous tumor-infiltrating lymphocyte (TIL) therapy in combination with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) in patients with advanced or metastatic refractory colon and rectal cancer. TILs are T cells naturally present in the patient's tumor. They are extracted from a biopsy, expanded in a specialized laboratory to large numbers, and reinfused into the patient following a preparative lymphodepletion regimen using cyclophosphamide and fludarabine. The addition of Pembrolizumab aims to block the PD-1 checkpoint and sustain T cell activity, while IL-2 provides a survival signal to the infused cells.
TIL therapy is scientifically compelling for colorectal cancer because TILs are already tumor-reactive — they have been primed against the patient's own cancer antigens. Unlike CAR-T cells, which require engineering to recognize a single antigen, TILs carry a polyclonal repertoire that may recognize multiple neoantigens, potentially addressing tumor heterogeneity and reducing the risk of antigen-escape relapse. Combining TILs with a PD-1 inhibitor may overcome the immunosuppressive tumor microenvironment that otherwise dampens T cell activity in solid tumors.
TIL therapy has shown significant promise in advanced melanoma, and its extension to gastrointestinal cancers including colorectal cancer is an active area of clinical development. Essen Biotech runs a parallel TIL program across multiple solid tumor types. This BAH248 trial is designed to characterize both the safety and the initial efficacy signal of this combined approach specifically in colorectal cancer patients.
CancerFax can help organize your medical records, prepare a structured case summary, and facilitate communication with the trial team at District One Hospital. We do not enroll patients directly — we help families navigate the process.
Trial at a Glance
A summary of the key details for this Phase I/II study. This information is drawn from the official ClinicalTrials.gov registry entry for NCT06530303.
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 that uses the patient's own immune cells, extracted from inside their tumor, expanded into billions of cells in a specialized laboratory, and returned to the body to fight cancer.
TIL therapy is combined with Pembrolizumab (Keytruda), a PD-1 checkpoint inhibitor that keeps T cells active and prevents them from being switched off by the tumor, and with Aldesleukin (Interleukin-2, IL-2), which acts as a growth factor to sustain the infused TILs. Before the TIL infusion, the patient receives a lymphodepletion regimen of cyclophosphamide and fludarabine to create 'space' in the immune system for the new cells to expand.
The full treatment course involves multiple steps spanning several weeks and requires inpatient hospital admission at District One Hospital, Beijing.
How the therapy works (in simple terms)
How it is given
A tumor sample is collected — via biopsy or surgical resection — to harvest tumor-infiltrating lymphocytes. This requires a suitable accessible tumor lesion.
The extracted TILs are sent to a specialist GMP laboratory where they are stimulated and expanded over several weeks to produce billions of tumor-reactive T cells.
Before TIL infusion, the patient receives cyclophosphamide and fludarabine for approximately 5–7 days. This non-myeloablative regimen depletes the existing immune cells to create space and a favorable environment for the incoming TILs.
The expanded autologous TILs are infused back into the patient intravenously. This is the core treatment step, performed under close inpatient monitoring at the trial hospital.
Following TIL infusion, Aldesleukin (IL-2) is given to promote TIL survival and expansion in vivo. Pembrolizumab is administered to block PD-1, sustain T cell activity, and counteract tumor immune suppression.
Patients are monitored closely for adverse events throughout their hospital stay and during regular follow-up visits. Tumor response is assessed by RECIST v1.1 imaging. Follow-up continues for up to 36 months.
Primary endpoint: Safety profile — incidence and severity of adverse events over 6 months. Secondary endpoints: Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS) — all assessed by RECIST v1.1 up to 36 months.
Who This Trial May Be For
This trial is designed for patients with advanced colorectal cancer who have exhausted standard treatment options and are seeking an innovative immunotherapy-based approach. The following profiles reflect patients most likely to meet eligibility criteria.
You have been diagnosed with primary, relapsed, or metastatic colorectal cancer (colon or rectal cancer) confirmed by histology. The trial is open to patients with locally advanced or systemically metastatic disease.
You have failed at least one standard treatment regimen, or there are no standard treatment options available for your current disease stage. This includes patients who have progressed on chemotherapy, targeted therapy, or prior immunotherapy.
You have at least one evaluable tumor lesion, and a tumor region accessible for biopsy or resection — or malignant body fluid from which TILs can be isolated. This is required for the TIL extraction step.
You have a Karnofsky score of ≥60% or an ECOG performance status of 0–2, indicating you are functional enough to tolerate the TIL manufacturing, lymphodepletion, and infusion process.
You meet the blood count, liver, kidney, and cardiac function thresholds defined in the protocol (e.g., ANC ≥1.5×10⁹/L, creatinine ≤1.5 mg/dL, ALT/AST ≤3×ULN). Full lab work within 7 days of enrollment will be required.
International patients must be willing and able to travel to District One Hospital in Beijing, China, for TIL extraction, lymphodepletion, infusion, and follow-up visits over the trial period. CancerFax can assist with logistics planning.
Eligibility Criteria
The following criteria are drawn from the official ClinicalTrials.gov registry for NCT06530303. They are provided for patient orientation only. Only the trial investigators can make a final eligibility determination after reviewing complete medical records.
check_circleInclusion Criteria — May Be Eligible
- ✓Age 16 to 90 years
- ✓Histologically confirmed primary, relapsed, or metastatic colorectal cancer (colon or rectal)
- ✓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 contraception from consent through 1 year after 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 a daily dose of prednisone >15 mg (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 is 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 toxicities determined by investigators to be non-safety-relevant)
- ×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 assessment, CancerFax recommends preparing the following documents before reaching out. Having these ready allows our team to prepare a structured medical summary for the trial center.
How the Trial Process May Work
From first inquiry to follow-up, the journey through a TIL therapy trial involves several stages. CancerFax supports patients at every step.
Contact CancerFax. Our team will collect your medical records and organize them into a structured summary for eligibility pre-assessment.
Your case is reviewed against the published trial criteria. CancerFax will communicate findings and, if appropriate, coordinate with the trial team at District One Hospital.
If the trial team expresses interest, CancerFax facilitates formal communication with the hospital and helps arrange a consultation appointment.
You travel to District One Hospital, Beijing, for formal screening — including lab tests, imaging, and biopsy assessment. The investigators confirm eligibility and explain the informed consent process.
Upon enrollment, tumor tissue is collected for TIL expansion. You remain in contact with the hospital during the manufacturing phase, then return for lymphodepletion, infusion, and inpatient monitoring.
Regular follow-up visits assess treatment response and manage any adverse events. Tumor response is measured by imaging at defined intervals over up to 36 months. CancerFax can assist with logistics for return visits.
Potential Benefits
Participating in a clinical trial may offer access to a treatment not otherwise available. The following potential benefits apply to this TIL therapy study.
TIL therapy uses the patient's own tumor-reactive immune cells, representing a highly personalized form of cancer treatment not commercially available for colorectal cancer outside of trials.
The combination of TIL cells, Pembrolizumab (PD-1 blockade), and IL-2 is designed to mount a multi-pronged immune attack, potentially enhancing depth and durability of any anti-tumor response.
This trial is specifically designed for patients who have exhausted standard options, offering a scientifically grounded pathway when conventional treatments are no longer effective.
Patients receive close clinical monitoring throughout treatment and follow-up — a level of attention that may benefit overall health management beyond the study's primary objectives.
Participation generates data that may shape future treatment options for colorectal cancer patients globally — a meaningful contribution to the field.
Clinical trials study whether new treatments work. Individual responses vary. CancerFax does not promise a clinical response or remission.
Risks and Side Effects
TIL therapy combined with Pembrolizumab and IL-2 carries a range of potential side effects. The trial's primary endpoint is safety characterization. Patients are closely monitored throughout.
Patients may experience fever, chills, low blood pressure, or other infusion-related reactions during or after TIL administration. Close inpatient monitoring is provided at the time of infusion.
Cyclophosphamide and fludarabine suppress the immune system and bone marrow. This increases the risk of infection, bleeding, and anemia during the preparatory phase. Supportive care is provided.
High-dose IL-2 can cause capillary leak syndrome, fever, hypotension, fluid retention, renal impairment, and cardiac arrhythmias. IL-2 dosing and schedule are carefully managed by the clinical team.
Pembrolizumab can trigger immune-mediated inflammation in any organ — including lung (pneumonitis), gut (colitis), liver (hepatitis), skin (rash), and endocrine glands. Most irAEs are manageable with steroids, but severe cases require treatment discontinuation.
Following lymphodepletion, patients are transiently immunocompromised and at elevated risk of serious bacterial, viral, or fungal infections. Prophylactic antibiotics and close monitoring are standard.
Most patients experience fatigue, nausea, and general malaise as a result of lymphodepletion and systemic immunotherapy. These effects are typically temporary and managed with supportive care.
In some cases, tumor samples may not yield sufficient TILs for expansion. If TIL manufacturing fails, the patient may not be able to proceed with this treatment. The team will discuss options in this scenario.
This list is not exhaustive. The trial investigators will explain all known and potential risks during the informed consent process. CancerFax does not provide medical advice.
Trial Location and Hospital Information
This trial is conducted at a single center in Beijing, China. International patients will need to plan travel and extended stays for the TIL manufacturing, treatment, and follow-up phases. CancerFax provides logistics and coordination support for international patients.
The trial site accepts international patients. CancerFax can assist with medical visa support, airport-to-hospital coordination, interpreter services, accommodation guidance, and communication with the trial team in English. Please reach out early, as coordination timelines can be significant for cell therapy trials.
Costs, Trial Coverage, and Patient Expenses
Clinical trials can significantly reduce the direct financial burden of treatment, but not all costs are covered. The table below provides a general guide based on standard industry practices for Phase I/II investigational cell therapy trials. Contact the trial center and CancerFax for case-specific guidance.
Coverage details should be confirmed directly with Essen Biotech and District One Hospital before enrollment. Costs may vary based on individual circumstances and trial protocol amendments.
Standard Treatment vs Clinical Trial
For patients with advanced refractory colorectal cancer who have exhausted standard options, this comparison illustrates how trial participation may differ from continuing supportive or palliative care.
How CancerFax Can Help
Accessing a specialized TIL therapy trial in China involves clinical, logistical, and communication challenges. CancerFax provides end-to-end navigation support so patients and families can focus on the care — not the coordination.
Our oncology team reviews your pathology, imaging, and treatment history and organizes them into a structured case summary aligned with the trial's eligibility criteria.
We map your clinical profile against the published inclusion and exclusion criteria and provide an honest, realistic assessment of whether formal trial screening is appropriate.
CancerFax communicates directly with the trial coordinator at District One Hospital in Beijing on your behalf, in English and Mandarin, to facilitate the formal referral and screening appointment.
We provide guidance on medical visa applications, airport transfers, accommodation near the trial hospital, and return visit planning for patients traveling internationally.
Our team provides interpreter support for medical consultations and assists with translating critical documents — ensuring nothing is lost between you and your clinical team.
From first contact through treatment and follow-up, CancerFax remains a point of contact — helping manage communication, coordinate logistics, and support the family through a 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 consenting to participate in a clinical trial, it is important to understand what participation involves. The following questions are a starting point for your conversation with the trial investigators.
Frequently Asked Questions
Ready to Explore This Trial?
If you or a loved one has been diagnosed with advanced colorectal cancer and standard treatments are no longer working, this TIL therapy trial may represent a meaningful option worth exploring. CancerFax will help you understand whether this trial may be appropriate, 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.