Engineered Anti-ALPP CAR-T Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors
An investigator-initiated study at Beijing GoBroad Hospital that evaluated an engineered anti-ALPP CAR-T cell therapy in adults with ALPP-positive recurrent or metastatic solid tumors. The sponsor has since terminated the trial as a strategic portfolio decision. CancerFax shares this information transparently and helps families explore other relevant ALPP-targeted, CAR-T and advanced cell therapy options.
About This Clinical Trial
Patients with recurrent or metastatic solid tumors who have exhausted standard chemotherapy, targeted therapy, immunotherapy or radiation often have very limited options. Cell therapies that have transformed certain blood cancers are now being explored carefully in solid tumors, where biological barriers like antigen heterogeneity, immune-suppressive tumor environments and on-target off-tumor toxicity make the path harder. Trials in this space are early, single-center and biomarker-driven, with strict eligibility requirements.
This trial, NCT07123493, was a single-arm, single-center, open-label investigator-initiated study run by Beijing GoBroad Hospital. It was designed to evaluate an engineered anti-ALPP CAR-T cell therapy in adults with ALPP-positive recurrent or metastatic solid tumors who had failed or were unsuitable for standard therapy. The trial opened in August 2025 and was terminated by the sponsor in December 2025 as a strategic portfolio decision rather than for a safety or efficacy reason recorded on the registry.
ALPP, also known as placental alkaline phosphatase or PLAP, is an oncofetal cell-surface protein. In normal adults it is largely restricted to placental tissue, but it is aberrantly expressed in several solid tumors including ovarian, endometrial, germ cell, gastric, pancreatic and some non-small cell lung cancers. This restricted normal-tissue expression is what makes ALPP an attractive target for selective immunotherapy approaches such as CAR-T cells, T-cell engagers and antibody-drug conjugates.
Although this specific trial is no longer recruiting, the underlying scientific rationale for targeting ALPP remains active worldwide. Other ALPP-directed cell therapy and bispecific T-cell engager programs are in early clinical development. CancerFax tracks these programs and helps patients understand the broader landscape so they can make informed decisions with their treating oncologist.
The study aimed to evaluate the safety, tolerability and early signals of activity of engineered anti-ALPP CAR-T cells in adults with biomarker-confirmed ALPP-positive advanced solid tumors who had progressed on prior therapy.
Trial at a Glance
A quick snapshot of the trial design, target and current status. This is a summary for orientation, not a confirmation of eligibility.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
The investigational therapy in this trial was an engineered anti-ALPP CAR-T cell product. CAR-T therapy involves collecting a patient's own T cells, genetically engineering them in a laboratory to recognise a specific tumor marker, growing them in large numbers, and then giving them back to the patient as a one-time infusion after a short course of preparatory chemotherapy.
In this study, the engineered T cells were designed to recognise ALPP, also called placental alkaline phosphatase, on the surface of solid tumor cells. Because ALPP is largely absent from healthy adult tissues outside the placenta, it is considered a relatively selective target for solid tumor immunotherapy.
How anti-ALPP CAR-T cells are intended to work
T cells are immune cells that normally identify and destroy abnormal cells. In CAR-T therapy, a patient's T cells are modified in a laboratory to carry a chimeric antigen receptor โ in this case, one that binds ALPP on the surface of tumor cells. When these engineered cells are infused back, they are designed to recognise ALPP-positive tumor cells, attach to them, activate, multiply at the tumor site and trigger killing of those cells. Anti-ALPP CAR-T programs target this antigen because it is expressed on the surface of several solid tumors but largely absent from normal adult organs, which may help reduce off-tumor effects compared with more broadly expressed targets.
Detailed history, performance status check, imaging, blood work, organ function tests, infection screening, and confirmation of ALPP positivity on tumor tissue by immunohistochemistry.
If the patient is enrolled, peripheral blood mononuclear cells are collected through a leukapheresis procedure to harvest enough T cells to engineer.
Collected T cells are sent to a manufacturing facility, genetically modified to express the anti-ALPP CAR, and expanded over several weeks under strict quality control.
A short course of lymphodepleting chemotherapy is given before infusion to help the engineered CAR-T cells expand and persist in the body.
The manufactured anti-ALPP CAR-T cells are infused back into the patient as a one-time treatment in a hospital setting equipped to manage CAR-T-specific reactions.
Patients are closely monitored as inpatients for cytokine release syndrome, neurological symptoms and blood count changes, and then followed for tumor response, persistence of CAR-T cells in blood, and long-term safety.
Anti-ALPP CAR-T cell therapy is not an approved treatment anywhere in the world. It was being studied in this early-phase trial, which is now closed. Decisions about cell therapy should always be made with a qualified oncology team.
Who This Trial May Be For
While this specific trial is no longer enrolling, the criteria below describe the kind of patient profile that the protocol was designed for. They are useful for understanding whether an ALPP-directed cell therapy approach is even worth discussing with an oncology team and whether to pursue ALPP testing.
Adults with advanced solid tumors that have come back or spread despite prior treatment, where standard approved therapies are no longer working or are not suitable.
Tumor tissue confirmed positive for ALPP, also called placental alkaline phosphatase or PLAP, by immunohistochemistry. ALPP is reported across ovarian, endometrial, germ cell, gastric, pancreatic and some lung tumors.
Patients who have already received and progressed on standard chemotherapy, immunotherapy, targeted therapy or radiotherapy, or for whom these options are not appropriate.
ECOG performance status 0 or 1 โ meaning the patient is fully active or restricted in physically strenuous activity but ambulatory and able to carry out light work.
Stable blood counts and adequate heart, liver, kidney and lung function, with no severe active infection or significant autoimmune disease, since CAR-T trials require the body to tolerate lymphodepletion and possible cytokine-driven reactions.
Cell therapy is given at a single center. Patients and a primary caregiver must be willing and logistically able to travel to Beijing, stay for the full treatment and inpatient monitoring period, and return for follow-up.
Eligibility Criteria
The criteria below are taken directly from the trial registry record for NCT07123493. They describe the patient profile the protocol was designed for. Meeting some criteria does not guarantee enrollment, and since the trial is now terminated, these criteria are also useful for screening interest in other ALPP-directed cell therapy programs.
check_circleInclusion Criteria โ May Be Eligible
- โParticipants must voluntarily provide written informed consent
- โAged 18 to 70 years (inclusive)
- โLife expectancy of at least 3 months
- โECOG performance status of 0 or 1
- โFailed standard therapy or unsuitable for available standard treatment
- โAt least one measurable lesion as per RECIST 1.1 criteria
- โALPP-positive tumor confirmed by immunohistochemistry
- โAdequate organ and bone marrow function
- โEffective contraception required for participants of childbearing potential
- โAdequate venous access for leukapheresis (T-cell collection)
cancelExclusion Criteria โ May Not Be Eligible
- รPrimary central nervous system (CNS) malignancy or uncontrolled CNS metastases
- รOther malignancies within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ
- รActive autoimmune disease or significant history of autoimmune disease
- รImmunodeficiency, including known HIV positivity
- รInherited or acquired bleeding disorders
- รClinically significant cardiovascular disease
- รActive infection, including tuberculosis, hepatitis B, hepatitis C or syphilis
- รPregnancy or breastfeeding
- รHistory of refractory epilepsy, active gastrointestinal bleeding or high risk of tumor-related bleeding
- รSevere systemic illness or significant psychiatric illness that would interfere with the trial
- รPrior cell therapy or gene therapy
- รSevere drug hypersensitivity history
- รAny other condition that, in the investigator's judgement, makes the participant unsuitable for the study
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
Whether a patient is being considered for this trial, a related ALPP-directed program, or another cell therapy, the same core set of medical documents is needed for any meaningful review. CancerFax helps families organise these records and present them to specialists in a clear and structured way.
How the Trial Process May Work
Cell therapy trials have more steps than most oncology trials, because the treatment is manufactured individually for each patient. The flow below describes how a patient would typically have moved through this protocol while it was open, and how CancerFax supports families through equivalent advanced therapy pathways elsewhere.
All available records โ diagnosis, pathology, scans, treatment history and any ALPP / PLAP testing already done โ are reviewed to see whether the patient profile fits the kind of trial being considered.
The treating oncologist or trial center reviews the case against inclusion and exclusion criteria. ALPP IHC may need to be repeated on a recent tumor sample if not already available.
If accepted for closer evaluation, the patient travels to the trial site for in-person screening including imaging, organ function tests and infection screening as per protocol.
The investigators explain the protocol, expected risks, monitoring requirements and follow-up. The patient signs the informed consent form before any trial-specific procedures begin.
T cells are collected via leukapheresis, sent for engineering and expansion, and infused back to the patient after a short course of lymphodepleting chemotherapy.
Patients are monitored as inpatients for cytokine release syndrome, neurological symptoms and blood count changes, then followed long-term for tumor response and persistence of CAR-T cells in peripheral blood.
Potential Benefits
Trials studying advanced cell therapies sometimes offer access to investigational approaches not available outside research. Even for closed trials, understanding what the study was trying to offer can help patients and families decide whether to pursue similar pathways at other centers.
While the trial was open, eligible patients had a chance to receive an engineered anti-ALPP CAR-T cell product not available outside a research setting.
Cell therapy trials at experienced centers involve hematology-oncology, solid tumor oncology, transfusion medicine, intensive care, infectious disease and pharmacy teams working together.
Trial patients are monitored more intensively than in routine care, with scheduled assessments for safety, response and biomarker tracking.
ALPP IHC testing required for this trial gives the patient information about a biomarker that may also be relevant for other ALPP-directed programs in development.
Patients participating in early CAR-T trials in solid tumors contribute to the broader scientific understanding of how cell therapies can be made safer and more effective beyond blood cancers.
Trials follow a fixed protocol with clear treatment steps, monitoring schedules and follow-up visits, which can help patients and families plan logistics and recovery.
Phase 1 cell therapy trials are designed primarily to study safety and dosing. A trial may or may not directly benefit the individual patient. Realistic expectations, honest conversations with the treating team and careful weighing of travel and cost are essential.
Risks and Side Effects
CAR-T cell therapy in solid tumors is still under active investigation worldwide. Trials in this space carry meaningful risks that are different from standard chemotherapy or immunotherapy. The categories below describe risk types associated with CAR-T cell therapy in general.
When CAR-T cells activate and multiply, they can release large amounts of inflammatory cytokines. This may cause fever, low blood pressure, low oxygen and other systemic symptoms. CRS can be mild to severe and is managed in centers experienced in cell therapy with supportive care and specific medications.
Even tumor-selective targets can sometimes be expressed at lower levels on certain normal tissues. ALPP is largely restricted to placenta in healthy adults, but any clinical signal of off-tumor binding in other organs is carefully monitored, especially in female reproductive tissues and in early-phase trials.
The lymphodepleting chemotherapy given before CAR-T infusion lowers white cells, red cells and platelets. Patients may need transfusions, growth factor support and protection from infection during the recovery period.
Some CAR-T recipients develop neurological symptoms such as confusion, tremor, difficulty with speech or, rarely, seizures. These are closely monitored as part of standard CAR-T care and most cases resolve with appropriate management.
Common, manageable side effects include fatigue, nausea, fever, mucositis and infection due to temporarily lowered immunity. These typically improve with supportive care over weeks.
Because anti-ALPP CAR-T is investigational and has been studied in only small numbers of patients to date, the long-term risk profile is not fully established. Long-term follow-up of CAR-T recipients is standard.
Time away from home, travel cost, uncertainty about response and the possibility that a trial may be paused, modified or terminated by the sponsor โ as happened with this study โ are all real factors. They should be weighed carefully with the family and treating team before pursuing any cell therapy pathway.
Trial Location and Hospital Information
This trial was conducted at a single site in Beijing, China โ Beijing GoBroad Hospital, a research-oriented hospital under the GoBroad Healthcare Group, located in the Changping Life Science Park. The hospital is known for hematologic and solid tumor cell therapy programs and runs a Phase I Clinical Trial Center built to international standards. With the trial now terminated, no new patients are being enrolled at this site for this specific protocol.
When a trial is closed, international patients still have meaningful options. Other ALPP-directed cell therapy and bispecific programs are in early clinical development at different centers, and CAR-T programs targeting other solid tumor antigens are progressing in China and elsewhere. CancerFax helps families verify trial status, translate and organise medical records, coordinate remote case reviews, plan visa and accommodation logistics, and explore parallel advanced therapy and clinical trial pathways suited to the specific cancer type and biomarker profile.
Costs, Trial Coverage, and Patient Expenses
Cost structures for early-phase, investigator-initiated cell therapy trials in China vary considerably between sponsors and sites. For this study, the registry does not publish a detailed cost breakdown, so the categories below are general guidance for ALPP-directed CAR-T programs of this kind. Final cost confirmation must come from the trial center in writing.
CancerFax helps families understand expected cost categories and what is typically covered by sponsors. Final confirmation must come from the trial center in writing, especially for closed protocols or replacement options being suggested by the hospital.
Standard Treatment vs Clinical Trial
It helps to compare what an early-phase cell therapy trial offers against approved standard treatment, so families can weigh both pathways realistically. The table below describes general differences, not specific outcomes for this trial.
How CancerFax Helps Patients Explore ALPP-Directed and Other Cell Therapy Options
CancerFax is a specialist cancer patient-navigation and advanced cancer treatment access platform. We are not a hospital or a sponsor. Our role is to help families understand complex options like ALPP-directed cell therapy, organise medical records properly, and connect with the right specialists and trial centers across China, India and other international cancer programs.
We help collect, translate and structure pathology, imaging, ALPP IHC, molecular reports and treatment history into a clear case summary that specialist centers can review quickly.
We help check whether a patient profile broadly fits ongoing ALPP-directed, CAR-T or related cell therapy programs, and we share what the most recent options look like in China and globally.
We coordinate with cell therapy programs at Beijing GoBroad Hospital, the wider GoBroad network and other leading Chinese cancer centers, and forward properly prepared case summaries for review.
We support visa documentation, travel planning, accommodation near the hospital and on-the-ground logistics for the patient and accompanying caregiver.
When a specific trial like NCT07123493 is closed, we help families understand what other advanced options โ including other CAR-T programs, T-cell engagers, antibody-drug conjugates and standard combinations โ may be relevant.
From initial enquiry to second opinions, scheduling, on-arrival coordination and post-treatment follow-up, CancerFax stays involved as a single point of contact for the family.
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
If a cell therapy trial is being considered, asking the right questions early helps protect the patient's time, money and hope. The list below is a starting point for conversations with the treating oncologist and trial team.
Frequently Asked Questions
Want to Understand ALPP-Directed Options Beyond This Trial?
Although NCT07123493 is closed, ALPP remains an active research target across several international programs. CancerFax can review the case, organise documents, confirm ALPP testing where needed and help families understand which advanced cell therapy and clinical trial pathways are realistically available.
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.
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ยฉ CancerFax ยท 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.