Solid TumorEarly Phase 1NCT07487597
Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
A Early Phase 1 study testing Enhanced ALPP CAR-T treatment in people with Solid Tumor, run by TCRCure Biopharma Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Enhanced ALPP CAR-T treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 28 Feb 2029
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must voluntarily provide written informed consent.
- Aged 18-70 years (inclusive).
- Life expectancy ≥ 3 months.
- ECOG performance status 0-1.
- Failed or unsuitable for standard therapy.
- At least one measurable lesion per RECIST 1.1.
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- ALPP-positive tumor confirmed by immunohistochemistry.
- Adequate organ and bone marrow function.
- Effective contraception required for participants of childbearing potential.
- Adequate venous access for leukapheresis.
Who cannot join
- Primary CNS malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
- Active autoimmune disease or history of autoimmune disease.
- Immunodeficiency, including HIV positivity.
- Bleeding disorders (inherited or acquired).
- Clinically significant cardiovascular disease.
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- Active infection (including tuberculosis, hepatitis B/C, syphilis).
- Pregnant or breastfeeding women.
- History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding.
- Severe systemic or psychiatric illness.
- Prior cell or gene therapy.
- Severe drug hypersensitivity history.
- Investigator-assessed unsuitability for trial participation.
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, 1 recruiting
- Recruiting
The Jinling Hospital
Nanjing, Jiangsu
Tangfeng Lv, MD, 02580863234, njzyjg80863256@163.com
About this study
Official title: A Single-Arm, Single-Center, Open-Label Pilot Study of Functionally Enhanced ALPP-Targeted Engineered T Cells for Patients With ALPP-Positive Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Read the detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of Enhanced ALPP CAR-T in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.
- Conditions
- Solid Tumor
- Being tested
- Enhanced ALPP CAR-T treatment
- Keywords
- Advanced Solid Tumor, ALPP, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced ALPP CAR-T treatmentBiological
Also called Fludarabine Cyclophosphamide
Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced ALPP CAR-T | Experimental | Following lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion. Receives: Biological: Enhanced ALPP CAR-T treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Enhanced ALPP CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Measured: Up to 24 months
Safety of Enhanced ALPP CAR-T cells
Incidence of DLT
Measured: Up to 1 month
Secondary outcomes (4)
Efficacy of Enhanced ALPP CAR-T cells
Optimal objective response rate (ORR)
Measured: Up to 24 months
To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
To detect ALPP CAR copies in peripheral blood, then calculated Cmax.
Measured: Up to 24 months
To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion
To detect ALPP CAR-T cell number in tumor tissues after infusion
Measured: Up to 24 months
To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
To detect ALPP CAR copies in peripheral blood, then calculated AUC.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start28 Feb 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCRCure Biopharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tangfeng Lv, MD, Principal investigator, The Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487597
- Sponsor's protocol ID
- ALPP-NJ003
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Open-Label Pilot Study of Functionally Enhanced ALPP-Targeted Engineered T Cells for Patients With ALPP-Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07487597
- Acronym / sponsor ID
- ALPP-NJ003
- Conditions
- Solid Tumor
- Keywords
- Advanced Solid Tumor, ALPP, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- TCRCure Biopharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 23 Mar 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.
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of Enhanced ALPP CAR-T in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced ALPP CAR-T | Experimental | Biological: Enhanced ALPP CAR-T treatmentFollowing lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must voluntarily provide written informed consent.
- Aged 18-70 years (inclusive).
- Life expectancy ≥ 3 months.
- ECOG performance status 0-1.
- Failed or unsuitable for standard therapy.
Key exclusion criteria (13 listed)
- Primary CNS malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
- Active autoimmune disease or history of autoimmune disease.
- Immunodeficiency, including HIV positivity.
- Bleeding disorders (inherited or acquired).
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 |
|---|---|---|
| Enhanced ALPP CAR-T treatmentAlso: Fludarabine CyclophosphamideEnhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide. | Biological | Enhanced ALPP CAR-T |
Primary outcome
Safety of Enhanced ALPP CAR-T cells
Time frame: Up to 24 months
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Safety of Enhanced ALPP CAR-T cells
Time frame: Up to 1 month
Incidence of DLT
4 secondary outcomes
Efficacy of Enhanced ALPP CAR-T cells
Time frame: Up to 24 months
To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
Time frame: Up to 24 months
To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion
Time frame: Up to 24 months
To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
Time frame: Up to 24 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 23 Mar 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
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.
Tangfeng Lv, MD principal investigator
The Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Enhanced ALPP CAR-T treatment in people with Solid Tumor, run by TCRCure Biopharma Ltd. 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Tangfeng LV, MD (02580863234, njzyjg80863256@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Enhanced ALPP CAR-T cells (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 23 Mar 2026.