Solid TumorsPhase 1/2NCT04627740
Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors
A Phase 1/2 study testing Retroviral vector-transduced autologous T cells to express anti-ALPP CARs in people with Solid Tumors, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Expected to survive more than 3 months
- PS 0-2
- Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%)
- Patients with no curative regimen to receive
- WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
- HBV DNA copy number less than 100/ml
- ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
- Understand this test and have signed informed consent
Who cannot join
- Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
- Decompensated liver cirrhosis, liver function Child-pugh C grade
- Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
- Long-term use of immunosuppressive agents after organ transplantation
- Screening indicated that the target cell transfection rate was less than 30%
- Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
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- Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
- Pregnant or lactating subjects
- In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
- Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official title: A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.
Read the detailed description
Primary Objectives:
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
- Conditions
- Solid Tumors
- Being tested
- Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroviral vector-transduced autologous T cells to express anti-ALPP CARsDrug
Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered
| Study group | Role | What they receive |
|---|---|---|
| CART treatment | Experimental | Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered Receives: Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients suffering treatment-related AE
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Measured: 1 year
Secondary outcomes (3)
Objective response rate to ALPP-CART infusion
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
Measured: Eight weeks
Progression-free survival to ALPP-CART infusion
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.
Measured: 6 months
Number of peripheral CAR-T after infusion
The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Dec 2020
- Primary completion28 Feb 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Responsible party
- Principal investigator, Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627740
- Sponsor's protocol ID
- TCRCureALPPCART
- Status last verified
- Jan 2026
- First submitted
- 5 Nov 2020
- Last updated
- 20 Jan 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 20 Jan 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 Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04627740
- Acronym / sponsor ID
- TCRCureALPPCART
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 13 Nov 2020 (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.
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.
Detailed description
Primary Objectives:
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART treatment | Experimental | Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARsCyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Expected to survive more than 3 months
- PS 0-2
- Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%)
- Patients with no curative regimen to receive
- WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
Key exclusion criteria (10 listed)
- Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
- Decompensated liver cirrhosis, liver function Child-pugh C grade
- Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
- Long-term use of immunosuppressive agents after organ transplantation
- Screening indicated that the target cell transfection rate was less than 30%
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 |
|---|---|---|
| Retroviral vector-transduced autologous T cells to express anti-ALPP CARsCyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered | Drug | CART treatment |
Primary outcome
Number of patients suffering treatment-related AE
Time frame: 1 year
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
3 secondary outcomes
Objective response rate to ALPP-CART infusion
Time frame: Eight weeks
Progression-free survival to ALPP-CART infusion
Time frame: 6 months
Number of peripheral CAR-T after infusion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Retroviral vector-transduced autologous T cells to express anti-ALPP CARs in people with Solid Tumors, run by Xinqiao Hospital of Chongqing 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 20 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients suffering treatment-related AE (time frame: 1 year). 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 20 Jan 2026.