Acute Myeloid LeukemiaPhase 1NCT07106749
CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies
A Phase 1 study testing CD180 CART in people with Acute Myeloid Leukemia and B Acute Lymphoblastic Leukemia/Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, B Acute Lymphoblastic Leukemia/Lymphoma
- What is being tested?
- CD180 CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2025to 28 Jun 2030
- Phase
- 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
- Age ≥18 and <70 years, regardless of gender;
- B-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);
- Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
- Cytology confirmed that the tumor cells were CD180 positive.
- Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
- Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition):
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- Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;
- CR after consolidation chemotherapy, relapse within 12 months;
- Relapse 12 months after remission but ineffective after conventional chemotherapy;
- 2 or more relapses;
- Relapse after hematopoietic stem cell transplantation.
- Meet the diagnosis of relapsed/refractory B-ALL/LBL, including any of the following:
- Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;
- Relapse within <12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;
- Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;
- Complies with diagnosis of other relapsed/refractory CD180 positive hematologic malignancies
- Creatine clearance >60ml/min (Cockcroft and Gault formula); serum total bilirubin ≤3 times the upper limit of normal, serum ALT and AST ≤5 times the upper limit of normal range for patients without liver invasion;
- Echocardiography showing left ventricular ejection fraction (LVEF) ≥50%;
- Pulse oxygen saturation ≥92%;
- The estimated survival time is more than 3 months;
- ECOG score 0-2;
- Subjects or their legal guardians voluntarily participate in this trial and sign the informed consent form.
Who cannot join
- Subjects who met any of the following criteria were excluded from the study:
- acute promyelocytic leukemia (APL);
- Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
- Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
- Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
- Systemic chemotherapy (except for pretreatment) within 1 week;
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- For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;
- Received donor lymphocyte infusion (DLI) within 6 weeks;
- Presence of uncontrolled, serious, active infection at screening;
- Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (>480ms) or serious arrhythmia judged by the investigator;
- Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;
- Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening;
- Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use);
- Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment;
- Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;
- Patients with a history of allergy to any component of cell products;
- Pregnant, lactating females, and subjects (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male subjects who plan to become pregnant within 1 year after cell infusion; female subjects or partners who plan to become pregnant within 1 year after cell infusion;
- Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.
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
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Wang Jianxiang, 022-23909120, wangjx@ihcams.ac.cn
Wang Ying
About this study
Official title: CD180 CART Cell Injection in the Treatment of Relapsed or Refractory CD180 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.
The objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies. In this single-arm, open-label, single-center, Phase I clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. CD180 CART cells will be administered intravenously using a 3+3 dose escalation and rapid titration design, with CART dose groups of (1) 0.5×10^6 CART cells/kg;(2)1×10^6 CART cells/kg; and (3) 3×10^6 CART cells/kg. Each cohort was planned to enroll 6-12 patients.
Read the detailed description
This study will utilize CD180 CART cells to treat CD180-positive relapsed or refractory hematological malignancies, especially AML and B-ALL/LBL patients. Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose for each cohort. 3+3 dose escalation CART dose groups were (1) 0.5×10^6 CART cells/kg; (2)1×10^6 CART cells/kg;(3) 3×10^6 CART cells/kg. A minimum of 6 and a maximum of 12 patients are expected to be enrolled in each cohort. Fludarabine and cyclophosphamide-based preconditioning should be performed within 1 week prior to CD180 CART infusion. CD180 CART can be infused on D-1 provided that the requirement of 24 hours after completion of preconditioning is met. The objective of the study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies.
- Being tested
- CD180 CART
- Keywords
- CD180 CAR-T, Acute myeloid leukemia (AML), B acute lymphoblastic leukemia/lymphoma (B-ALL/LBL), Prospective study, Single-arm Clinical Study
- Medical subject headings
- Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD180 CARTBiological
Subjects screened to meet the requirements for CD180 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to CD180 CART infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of CD180 CART must be performed 24 hours after completion of chemotherapy preconditioning. CD180 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.
| Study group | Role | What they receive |
|---|---|---|
| CD180 CART | Experimental | Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose for each cohort. 3+3 dose escalation CART dose groups were (1) 0.5×10^6 CART cells/kg;(2)1×10^6 CART cells/kg;(3) 3×10^6 CART cells/kg. A minimum of 6 and a maximum of 12 patients are expected to be enrolled in each cohort. Receives: Biological: CD180 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Any toxicity associated with CD180 CART cells, or life-threatening hematological or non-hematological toxicity.
Measured: 3 months after CD180 CART cells infusion
Number of adverse event of CD180 CART cells treatment
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Secondary outcomes (6)
Response rate in 3 months
Measured: within 3 months after CD180 CART cells infusion
Duration of remission (DOR)
Time to first CR/CRi + PR (B-ALL/LBL) or CRc + PR (AML) to disease relapse or death due to leukemia after CD180 CART infusion.
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Event-free survival (EFS)
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Leukemia-free Survival (LFS)
Time from first CR/CRi (ALL/LBL) or CRc (AML) to relapse or death.
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Proportion of patients receiving hematopoietic stem cell
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Overall survival (OS)
Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start28 Jun 2025
- Primary completion28 Jun 2028 (estimated)
- Study completion28 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106749
- Sponsor's protocol ID
- IIT2025076
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD180 CART Cell Injection in the Treatment of Relapsed or Refractory CD180 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.
- ClinicalTrials.gov ID
- NCT07106749
- Acronym / sponsor ID
- IIT2025076
- Keywords
- CD180 CAR-T, Acute myeloid leukemia (AML), B acute lymphoblastic leukemia/lymphoma (B-ALL/LBL), Prospective study, Single-arm Clinical Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 28 Jun 2028 (estimated)
- Study completion
- 28 Jun 2030 (estimated)
- First posted
- 6 Aug 2025 (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 objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies. In this single-arm, open-label, single-center, Phase I clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. CD180 CART cells will be administered intravenously using a 3+3 dose escalation and rapid titration design, with CART dose groups of (1) 0.5×10^6 CART cells/kg;(2)1×10^6 CART cells/kg; and (3) 3×10^6 CART cells/kg. Each cohort was planned to enroll 6-12 patients.
Detailed description
This study will utilize CD180 CART cells to treat CD180-positive relapsed or refractory hematological malignancies, especially AML and B-ALL/LBL patients. Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose for each cohort. 3+3 dose escalation CART dose groups were (1) 0.5×10^6 CART cells/kg; (2)1×10^6 CART cells/kg;(3) 3×10^6 CART cells/kg. A minimum of 6 and a maximum of 12 patients are expected to be enrolled in each cohort. Fludarabine and cyclophosphamide-based preconditioning should be performed within 1 week prior to CD180 CART infusion. CD180 CART can be infused on D-1 provided that the requirement of 24 hours after completion of preconditioning is met. The objective of the study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD180 CART | Experimental | Biological: CD180 CARTTwo cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose for each cohort. 3+3 dose escalation CART dose groups were (1) 0.5×10^6 CART cells/kg;(2)1×10^6 CART cells/kg;(3) 3×10^6 CART cells/kg. A minimum of 6 and a maximum of 12 patients are expected to be enrolled in each cohort. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18 and <70 years, regardless of gender;
- B-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);
- Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
- Cytology confirmed that the tumor cells were CD180 positive.
- Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
Key exclusion criteria (18 listed)
- acute promyelocytic leukemia (APL);
- Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
- Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
- Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
- Presence of uncontrolled, serious, active infection at screening;
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 |
|---|---|---|
| CD180 CARTSubjects screened to meet the requirements for CD180 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to CD180 CART infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of CD180 CART must be performed 24 hours after completion of chemotherapy preconditioning. CD180 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met. | Biological | CD180 CART |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: 3 months after CD180 CART cells infusion
Any toxicity associated with CD180 CART cells, or life-threatening hematological or non-hematological toxicity.
Number of adverse event of CD180 CART cells treatment
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
6 secondary outcomes
Response rate in 3 months
Time frame: within 3 months after CD180 CART cells infusion
Duration of remission (DOR)
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Event-free survival (EFS)
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Leukemia-free Survival (LFS)
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Proportion of patients receiving hematopoietic stem cell
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Overall survival (OS)
Time frame: Participants will be followed for the duration of the treatment, an expected average of 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 6 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD180 CART in people with Acute Myeloid Leukemia and B Acute Lymphoblastic Leukemia/Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 22 inclusion and 18 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 6 Aug 2025. 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?
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.
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 Jianxiang Wang (+862223909120, wangjx@ihcams.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: 3 months after CD180 CART cells infusion). 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 6 Aug 2025.