Advanced Solid TumorsPhase 1/2NCT06556108
ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors
A Phase 1/2 study testing ALPP CAR-T cells, Fludarabine and Cyclophosphamide in people with Advanced Solid Tumors, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Alkaline phosphatase (ALP) is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values. As one of the earliest discovered oncofetal antigens, ALP has emerged as a significant biomarker for various malignant tumors, such as ovarian cancer, breast cancer, trophoblastic tumors, germ… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ALPP CAR-T cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
- Age 18-70 (including boundary value), both male and female;
- Expected life span is more than 3 months from the date of signing the informed consent;
- ECOG score 0-1;
- Metastatic or recurrent solid tumors confirmed by histopathology;
- Refractory to standard treatment evaluated by radiological assessment;
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- Be able provide fresh or preserved tissue specimen;
- At least 1 measurable lesion (according to RECIST 1.1);
- ALPP expression positivity determined by IHC；
- The organ marrow function of the subjects meets the following requirements:
- Marrow function：ANC≥ 1.5×109/L; PLT count≥ 75×109/L; HGB≥ 90 g/L;
- Coagulation function: Prothrombin Time (PT)≤ 1.5 times the Upper Limit of Normal (ULN), International Normalized Ratio (INR)≤ 1.5 times ULN, and Activated Partial Thromboplastin Time (APTT)≤ 1.5 times ULN;
- Liver function: ALT and AST≤ 2.5 times ULN (in cases of liver transfer/infiltration, ≤ 5.0 times ULN); Total Bilirubin (TBIL) ≤ 1.5 times ULN (with Gilbert's syndrome, <3×ULN);
- Renal function: Serum Creatinine (Cr)≤ 1.5 times ULN or Creatinine Clearance Rate (CrCl) ≥ 60ml/min;
- Cardiac function: Left Ventricular Ejection Fractions (LVEF)≥45%;
- Pulmonary function: Forced Expiratory Volume in the first second (FEV1) ≥ 50%.
- Prior to the first dose, subjects must have recovered from toxic effects of previous treatment (CTCAE grade ≤ 1, with the exception of specific criteria such as "alopecia"), and the investigator determines that the corresponding adverse events do not pose a safety risk.
- For male or female subjects of childbearing potential: from the time of signing the ICF until at least 24 weeks after the last dose, they must agree to practice abstinence or use effective contraceptive methods, including intrauterine devices, etc.
- Note: Women of childbearing potential who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy, or salpingectomy) or who have been postmenopausal for more than 24 months are considered to have no potential for pregnancy.
- A suitable venous access for the necessary blood collection can be established, and there are no contraindications for leukapheresis.
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
- Age 18-70 (including boundary value), both male and female;
- Expected life span is more than 3 months from the date of signing the informed consent;
- ECOG score 0-1;
- Metastatic or recurrent solid tumors confirmed by histopathology;
- Refractory to standard treatment evaluated by radiological assessment;
- Be able provide fresh or preserved tissue specimen;
- At least 1 measurable lesion (according to RECIST 1.1);
- ALPP expression positivity determined by IHC；
- The organ marrow function of the subjects meets the following requirements:
- Marrow function：ANC≥ 1.5×109/L; PLT count≥ 75×109/L; HGB≥ 90 g/L;
- Coagulation function: Prothrombin Time (PT)≤ 1.5 times the Upper Limit of Normal (ULN), International Normalized Ratio (INR)≤ 1.5 times ULN, and Activated Partial Thromboplastin Time (APTT)≤ 1.5 times ULN;
- Liver function: ALT and AST≤ 2.5 times ULN (in cases of liver transfer/infiltration, ≤ 5.0 times ULN); Total Bilirubin (TBIL) ≤ 1.5 times ULN (with Gilbert's syndrome, <3×ULN);
- Renal function: Serum Creatinine (Cr)≤ 1.5 times ULN or Creatinine Clearance Rate (CrCl) ≥ 60ml/min;
- Cardiac function: Left Ventricular Ejection Fractions (LVEF)≥45%;
- Pulmonary function: Forced Expiratory Volume in the first second (FEV1) ≥ 50%.
- Prior to the first dose, subjects must have recovered from toxic effects of previous treatment (CTCAE grade ≤ 1, with the exception of specific criteria such as "alopecia"), and the investigator determines that the corresponding adverse events do not pose a safety risk.
- For male or female subjects of childbearing potential: from the time of signing the ICF until at least 24 weeks after the last dose, they must agree to practice abstinence or use effective contraceptive methods, including intrauterine devices, etc.
- Note: Women of childbearing potential who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy, or salpingectomy) or who have been postmenopausal for more than 24 months are considered to have no potential for pregnancy.
- A suitable venous access for the necessary blood collection can be established, and there are no contraindications for leukapheresis.
Who cannot join
- Subjects with primary central nervous system (CNS) malignancies; subjects with CNS metastases who have failed local treatment; subjects without symptomatic brain metastases within 14 days before pretreatment, or with stable clinical symptoms and no requirement for corticosteroids or other treatment for brain metastases, may be included;
- Prior history of malignancy with non-target indications within the past 5 years, with the exception of: adequately treated malignancies, with more than 5 years of stability and minimal risk of recurrence as judged by the investigator; and in situ carcinoma without evidence of recurrence after adequate treatment;
- Subjects with any active autoimmune disease, history of autoimmune disease, or requiring systemic corticosteroids (≥10 mg/day prednisone equivalent) or immunosuppressive therapy, or syndromes (subjects with skin diseases that do not require systemic treatment or have resolved childhood asthma/allergies without any intervention as an adult; subjects with stable thyroid hormone replacement therapy for autoimmune hypothyroidism may be included);
- History of immunodeficiency, including positive HIV testing or other acquired or congenital immunodeficiency diseases;
- History of hereditary or acquired bleeding disorders;
- Presence of cardiovascular clinical conditions or symptoms, including: a. History of thromboembolic events ≥ grade 3 in the past 6 months, or currently receiving thrombolytic or anticoagulant therapy due to high thrombotic risk; b. Chronic heart failure with reduced ejection fraction (NYHA class ≥ II); c. History of unstable angina; d. Myocardial infarction in the past 6 months; e. Clinically significant malignant arrhythmias (excluding atrial fibrillation, paroxysmal supraventricular tachycardia); f. Clinically significant QTcF prolongation (QTcF > 450 ms for males, QTcF > 470 ms for females, derived from Fridericia's formula); g. Poorly controlled hypertension.
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- Presence of active infection (fever due to tumor growth may be included as judged by the investigator);
- Active pulmonary tuberculosis detected by history or CT scan, or history of active pulmonary tuberculosis within the past 1 year before inclusion, or history of active pulmonary tuberculosis more than 1 year ago without proper treatment;
- Patients with active hepatitis B or hepatitis C virus infection (active hepatitis B defined as hepatitis B virus deoxyribonucleic acid (HBV-DNA) > the lower limit of detection; active hepatitis C defined as hepatitis C virus ribonucleic acid (HCV-RNA) > the lower limit of detection) or positive syphilis serology;
- Pregnant or lactating women, or subjects with a positive blood pregnancy test;
- Serious surgery or major trauma within 28 days before lymphodepletion;
- Vaccination with live or attenuated vaccines within 28 days before Lymphodepletion;
- Systemic corticosteroids (excluding inhaled therapy, topical treatment, or physiological replacement therapy) or other immunosuppressive treatments within 14 days before lymphodepletion;
- Receiving any investigational drug or participating in another clinical study within 28 days before lymphodepletion (except for subjects participating in observational, non-interventional clinical studies, or in the survival follow-up period of an interventional clinical study);
- Refractory or persistent seizures, significant pleural or abdominal effusions, active gastrointestinal bleeding, or subjects judged by the investigator to be at high risk of significant bleeding due to tumor necrosis;
- Concomitant severe organic or psychiatric diseases;
- Prior history of allogeneic bone marrow or solid organ transplantation, or renal replacement therapy;
- Under the investigator's judgment, subjects with uncontrollable tumor-related pain or compression symptoms due to a large tumor burden that requires palliative treatment or radiation therapy should have completed treatment before entering the study;
- History of substance abuse, or alcohol or drug abuse;
- Prior cellular therapy (TCR-T, CAR-T, TIL, etc);
- Prior severe allergic reaction to any drug or its components in this trial;
- Subjects whose condition is judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official title: A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CAR-T Cells for Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumors
Alkaline phosphatase (ALP) is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values. As one of the earliest discovered oncofetal antigens, ALP has emerged as a significant biomarker for various malignant tumors, such as ovarian cancer, breast cancer, trophoblastic tumors, germ cell tumors, endometrial cancer, testicular tumors, cervical intraepithelial neoplasia, and gastrointestinal tumors.
Read the detailed description
This is a single-center, open-label, study of CAR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
Objective:
To evaluate the safety and efficacy of CAR-T cells in the treatment of advanced solid tumors.
Eligibility:
Adults aging 18-70 with advanced solid tumors
Design:
- Patients will undergo a comprehensive set of screening tests, including imaging procedures, evaluation of cardiac and pulmonary function, as well as a range of laboratory assessments.
- After meeting the eligibility criteria and enrolling in the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, which will be sent to manufacturing facilities.
- Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy followed by the infusion of ALPP CAR T-cells.
- Conditions
- Advanced Solid Tumors
- Being tested
- ALPP CAR-T cells, Fludarabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPP CAR-T cellsBiological
T cells genetically engineered with a CAR targeting ALPP (ALPP CAR) that display specific reactivity against ALPP target cells
FludarabineDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
CyclophosphamideDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | This clinical study consists of 4 dose groups, with dose groups 1 and 2 using an accelerated titration dose escalation method, and dose groups 3 and 4 using a "3+3" dose escalation method.
Interventions:
Biological: CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide Receives: Biological: ALPP CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality assessed by the principal investigator (PI). These should be possibly related to ALPP CAR-T cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. The MTD is the highest dose at which no more than one out of six patients experiences DLT, or the highest dose level tested if no DLTs are observed across all dose levels.
Measured: Day 28 post-initial ALPP CAR-T infusion
Overall response rate
The efficacy of ALPP CAR-T is assessed by the objective response rate (ORR) according to RECIST 1.1 and iRECIST. ORR is defined as patients who have achieved either a partial response (PR) or a complete response (CR).
Measured: Day 0 - Day 730
Treatment-related adverse events as assessed by CTCAE v5.0
The type, incidence and severity of adverse events include clinically significant post-treatment abnormal laboratory examination results, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory AEs will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0.
Measured: Day 0 - Day 730
Secondary outcomes (5)
Duration of response
The efficacy of ALPP CAR-T will be assessed by duration of response (DOR). The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
Measured: Day 0 - Day 730
Progression free survival
The efficacy of ALPP CAR-T will be assessed by progression free survival (PFS). The PFS refers to the time from treatment to progressive disease or death for any reason.
Measured: Day 0 - Day 730
Overall survival
The efficacy of ALPP CAR-T will be assessed by overall survival (OS). The OS refers to the time from treatment to death.
Measured: Day 0 - Day 730
Expansion and persistence of ALPP CAR-T cells in peripheral blood or serous effusion (if present)
Blood and serous effusion (if present) samples were collected to measure persistence of infused ALPP CAR-T using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).
Measured: Day 0 - Day 730
Cell cytokine levels and tumor biomarkers in peripheral blood and serous effusion (if present)
Blood samples and serous effusion (if present) were collected to measure cytokines IL-6, TNF-α, IL-8, IFN-γ, C-reactive protein (CRP), as well as ALPP concentration, Alpha-fetoprotein (AFP), Human chorionic gonadotropin (hCG), etc.
Measured: Day 0 - Day 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jan 2018
- Primary completion30 Jan 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Responsible party
- Principal investigator, Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
- Investigators
- Qingzhu Jia, M.D., Principal investigator, Xinqiao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556108
- Sponsor's protocol ID
- XQDC20191101
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2022
- 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 CAR-T Cells for Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06556108
- Acronym / sponsor ID
- XQDC20191101
- Conditions
- Advanced 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
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Aug 2024 (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.
Alkaline phosphatase (ALP) is a membrane-bound glycoprotein that catalyzes the hydrolysis of phosphates at alkaline pH values. As one of the earliest discovered oncofetal antigens, ALP has emerged as a significant biomarker for various malignant tumors, such as ovarian cancer, breast cancer, trophoblastic tumors, germ cell tumors, endometrial cancer, testicular tumors, cervical intraepithelial neoplasia, and gastrointestinal tumors.
Detailed description
This is a single-center, open-label, study of CAR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
Objective:
To evaluate the safety and efficacy of CAR-T cells in the treatment of advanced solid tumors.
Eligibility:
Adults aging 18-70 with advanced solid tumors
Design:
- Patients will undergo a comprehensive set of screening tests, including imaging procedures, evaluation of cardiac and pulmonary function, as well as a range of laboratory assessments.
- After meeting the eligibility criteria and enrolling in the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, which will be sent to manufacturing facilities.
- Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy followed by the infusion of ALPP CAR T-cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: ALPP CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideThis clinical study consists of 4 dose groups, with dose groups 1 and 2 using an accelerated titration dose escalation method, and dose groups 3 and 4 using a "3+3" dose escalation method. Interventions: Biological: CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
- Age 18-70 (including boundary value), both male and female;
- Expected life span is more than 3 months from the date of signing the informed consent;
- ECOG score 0-1;
- Metastatic or recurrent solid tumors confirmed by histopathology;
Key exclusion criteria (22 listed)
- Subjects with primary central nervous system (CNS) malignancies; subjects with CNS metastases who have failed local treatment; subjects without symptomatic brain metastases within 14 days before pretreatment, or with stable clinical symptoms and no requirement for corticosteroids or other treatment for brain metastases, may be included;
- Prior history of malignancy with non-target indications within the past 5 years, with the exception of: adequately treated malignancies, with more than 5 years of stability and minimal risk of recurrence as judged by the investigator; and in situ carcinoma without evidence of recurrence after adequate treatment;
- Subjects with any active autoimmune disease, history of autoimmune disease, or requiring systemic corticosteroids (≥10 mg/day prednisone equivalent) or immunosuppressive therapy, or syndromes (subjects with skin diseases that do not require systemic treatment or have resolved childhood asthma/allergies without any intervention as an adult; subjects with stable thyroid hormone replacement therapy for autoimmune hypothyroidism may be included);
- History of immunodeficiency, including positive HIV testing or other acquired or congenital immunodeficiency diseases;
- History of hereditary or acquired bleeding disorders;
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 |
|---|---|---|
| ALPP CAR-T cellsT cells genetically engineered with a CAR targeting ALPP (ALPP CAR) that display specific reactivity against ALPP target cells | Biological | Arm 1 |
| FludarabinePart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | Arm 1 |
| CyclophosphamidePart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | Arm 1 |
Primary outcome
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Time frame: Day 28 post-initial ALPP CAR-T infusion
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality assessed by the principal investigator (PI). These should be possibly related to ALPP CAR-T cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. The MTD is the highest dose at which no more than one out of six patients experiences DLT, or the highest dose level tested if no DLTs are observed across all dose levels.
Overall response rate
Time frame: Day 0 - Day 730
The efficacy of ALPP CAR-T is assessed by the objective response rate (ORR) according to RECIST 1.1 and iRECIST. ORR is defined as patients who have achieved either a partial response (PR) or a complete response (CR).
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 0 - Day 730
The type, incidence and severity of adverse events include clinically significant post-treatment abnormal laboratory examination results, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory AEs will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0.
5 secondary outcomes
Duration of response
Time frame: Day 0 - Day 730
Progression free survival
Time frame: Day 0 - Day 730
Overall survival
Time frame: Day 0 - Day 730
Expansion and persistence of ALPP CAR-T cells in peripheral blood or serous effusion (if present)
Time frame: Day 0 - Day 730
Cell cytokine levels and tumor biomarkers in peripheral blood and serous effusion (if present)
Time frame: Day 0 - Day 730
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.
Qingzhu Jia, M.D. principal investigator
Xinqiao Hospital
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 ALPP CAR-T cells, Fludarabine and Cyclophosphamide in people with Advanced 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 40 inclusion and 22 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?
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD) (time frame: Day 28 post-initial ALPP CAR-T infusion). The study lists 3 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 20 Jan 2026.