B-Acute Lymphoblastic LeukemiaPhase 1NCT07539610

Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors

A Phase 1 study testing Sup19 CAR-T in people with B-Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia/Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research Read more about this study

Who is it for?: Ages 18 to 69 years
Conditions the study is for: B-Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia/Lymphoma
What is being tested?: Sup19 CAR-T
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: Apr 2026to Nov 2027
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 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged ≥18 and <70 years, of any gender;
diagnosed with B-ALL/LBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);
meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression;
At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and/or extramedullary lesions;
Meeting the diagnosis of relapsed/refractory B-ALL/LBL, including any of the following situations: a. Primary refractory patients who have not achieved complete remission after two cycles of standardized chemotherapy or patients who have not achieved complete remission after multiple salvage chemotherapy regimens; b. Patients who relapse within 12 months after achieving complete remission or relapse after 12 months of achieving complete remission and have not achieved complete remission after one or more courses of standard treatment induction; c. Patients who relapse after hematopoietic stem cell transplantation or after CAR-T therapy targeting the same target;
Other relapsed/refractory CD19 weakly expressing hematological malignancies;

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Creatinine clearance rate > 60 ml/min (Cockcroft and Gault formula); for patients without liver involvement, total serum bilirubin < 3 times the upper limit of normal, and both serum ALT and AST < 5 times the upper limit of the normal range.
Echocardiography shows left ventricular ejection fraction (LVEF) of 250%;
Finger pulse oxygen saturation > 92%;--Estimated survival period of more than 3 months;
Estimated survival period of more than 3 months;
ECOG score of 0-2;
The subject or his/her legal guardian voluntarily participates in this trial and signs the informed consent form.

Who cannot join

Acute promyelocytic leukemia (APL);
presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;
uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;
prior administration of antineoplastic therapy before infusion; exclusion criteria include: a. Received systemic chemotherapy within 1 week (excluding pre-treatment); b. Those who have received monoclonal antibody treatment, with the time from the last monoclonal antibody infusion to the screening being less than 5 half-lives or 4 weeks (whichever is shorter); c. Received donor lymphocyte infusion (DLI) within 6 weeks;
Had uncontrolled severe active infection at screening;
Had a history of severe heart disease, including: severe heart dysfunction (according to the New York Heart Association (NYHA) cardiac function classification criteria, subjects with grade III or V cardiac dysfunction), myocardial infarction within 12 months or undergoing coronary angioplasty or stent placement, unstable angina pectoris, or electrocardiogram indicating a significantly prolonged QT interval (>480ms) or the investigator determined severe arrhythmia;

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Had a history of head trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, or cerebrovascular hemorrhagic disease, and required medication within the past 6 months;
Had hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL at screening; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; EBER positive or EBV copy number > upper limit of normal;
Those who require the use of steroid hormones during CAR-T infusion (except for those using inhaled steroid hormones locally); subjects who are receiving systemic steroid treatment before screening and whose study investigators determine that they need long-term systemic steroid treatment during the treatment period (excluding those using inhaled or local steroid hormones);
Subjects with treatable autoimmune diseases, immunodeficiency or those requiring immunosuppressive therapy;
Subjects who had acute graft-versus-host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening;
Subjects with a history of allergy to any component of the cell product;
Pregnant or lactating women, as well as male or female subjects who have reproductive capacity and cannot take effective contraceptive measures within 1 year after cell infusion (regardless of gender); male subjects who plan to conceive within 1 year after cell infusion; female subjects or their partners who plan to conceive within 1 year after cell infusion;
Any situation that the investigator considers may increase the risk for the subject or interfere with the test results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

wangying PI contact

15900225626

wangying1@ihcams.ac.cn

China1 site

Institute of Hematology, Chinese Academy of Medical Sciences & Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors: A Prospective, Single-Arm Clinical Study

Conditions: B-Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia/Lymphoma
Being tested: Sup19 CAR-T
Medical subject headings: Burkitt Lymphoma, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sup19 CAR-TBiological
The use of Sup19 CAR-T cells to treat hematologic malignancies with prior CD19-targeted therapy failure or CD19 weak expression aims to improve the relapse-free survival rate in patients with hematologic malignancies, providing a novel curative strategy for these patients.

Study groups in NCT07539610
Study group	Role	What they receive
3 dose groups	Experimental	Using a dose escalation and rapid titration design, the CAR-T dose groups were (1) 0.5×10^6 CAR-T cells/kg; (2) 1×10^6 CAR-T cells/kg; (3) 3×10^6 CAR-T cells/kg. Receives: Biological: Sup19 CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety evaluation of Sup19 CAR-T cell therapy in patients with hematologic malignancies who have failed prior CD19-targeted therapy or exhibit weak CD19 expression: dose-limiting toxicity (DLT) adverse events (with particular focus on CRS and ICANS)
Measured: up to 28 after CAR-T cell infusion

Secondary outcomes (7)

The best response rate of Sup19 CAR-T cell therapy within 3 months(The proportion of patients achieving CR/CRi)
Measured: Sup19 CAR-T cell therapy within 3 months
Duration of response (DOR)
Measured: After the Sup19 CAR-T infusion, the time from the first achievement of CR/CRi + PR to disease recurrence or death due to leukemia (follow-up monitoring until 3 years after infusion).
Event-free Survival, (EFS）
Measured: The time from the administration of Sup19 CAR-T to the earliest occurrence of the event (follow-up monitoring until 3 years after infusion)
Leukemia-free Survival, (LFS）
Measured: The time from the first occurrence of CR/CRi (ALL/LBL) to recurrence or death. (follow-up monitoring until 3 years after infusion)
The proportion of patients who received hematopoietic stem cell transplantation under the alleviated condition
Measured: The proportion of subjects who achieved remission after infusion and who received HSCT. (Follow-up monitoring was conducted until 3 years after the infusion)
Overall Survival,(OS）
Measured: The time from the first infusion of CAR-T cells to death due to any cause (Follow-up monitoring was conducted until 3 years after the infusion)
Negative rate of Minimal Residual Disease（MRD）
Measured: 28 days after the Sup19 CAR-T infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2026Nov 2027

First posted20 Apr 2026
Study startApr 2026 (estimated)
Primary completionNov 2027 (estimated)
Study completionNov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for B-Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
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
Model description: Sup19 CAR-T
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07539610
Sponsor's protocol ID: IIT2025126
Status last verified: Apr 2026
First submitted: 15 Jan 2026
Last updated: 20 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors: A Prospective, Single-Arm Clinical Study
ClinicalTrials.gov ID: NCT07539610
Acronym / sponsor ID: IIT2025126
Conditions: B-Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia/Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 9 participants (estimated)
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
Study start: Apr 2026 (estimated)
Primary completion: Nov 2027 (estimated)
Study completion: Nov 2027 (estimated)
First posted: 20 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Sup19 CAR-T

Arm	Type	Receives
3 dose groups	Experimental	Biological: Sup19 CAR-TUsing a dose escalation and rapid titration design, the CAR-T dose groups were (1) 0.5×10^6 CAR-T cells/kg; (2) 1×10^6 CAR-T cells/kg; (3) 3×10^6 CAR-T cells/kg.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients aged ≥18 and <70 years, of any gender;
diagnosed with B-ALL/LBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);
meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression;
At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and/or extramedullary lesions;
Meeting the diagnosis of relapsed/refractory B-ALL/LBL, including any of the following situations: a. Primary refractory patients who have not achieved complete remission after two cycles of standardized chemotherapy or patients who have not achieved complete remission after multiple salvage chemotherapy regimens; b. Patients who relapse within 12 months after achieving complete remission or relapse after 12 months of achieving complete remission and have not achieved complete remission after one or more courses of standard treatment induction; c. Patients who relapse after hematopoietic stem cell transplantation or after CAR-T therapy targeting the same target;

Key exclusion criteria (14 listed)

Acute promyelocytic leukemia (APL);
presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;
uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;
prior administration of antineoplastic therapy before infusion; exclusion criteria include: a. Received systemic chemotherapy within 1 week (excluding pre-treatment); b. Those who have received monoclonal antibody treatment, with the time from the last monoclonal antibody infusion to the screening being less than 5 half-lives or 4 weeks (whichever is shorter); c. Received donor lymphocyte infusion (DLI) within 6 weeks;
Had uncontrolled severe 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
Sup19 CAR-TThe use of Sup19 CAR-T cells to treat hematologic malignancies with prior CD19-targeted therapy failure or CD19 weak expression aims to improve the relapse-free survival rate in patients with hematologic malignancies, providing a novel curative strategy for these patients.	Biological	3 dose groups

Primary outcome

Safety evaluation of Sup19 CAR-T cell therapy in patients with hematologic malignancies who have failed prior CD19-targeted therapy or exhibit weak CD19 expression: dose-limiting toxicity (DLT) adverse events (with particular focus on CRS and ICANS)
Time frame: up to 28 after CAR-T cell infusion

7 secondary outcomes

The best response rate of Sup19 CAR-T cell therapy within 3 months(The proportion of patients achieving CR/CRi)
Time frame: Sup19 CAR-T cell therapy within 3 months
Duration of response (DOR)
Time frame: After the Sup19 CAR-T infusion, the time from the first achievement of CR/CRi + PR to disease recurrence or death due to leukemia (follow-up monitoring until 3 years after infusion).
Event-free Survival, (EFS）
Time frame: The time from the administration of Sup19 CAR-T to the earliest occurrence of the event (follow-up monitoring until 3 years after infusion)
Leukemia-free Survival, (LFS）
Time frame: The time from the first occurrence of CR/CRi (ALL/LBL) to recurrence or death. (follow-up monitoring until 3 years after infusion)
The proportion of patients who received hematopoietic stem cell transplantation under the alleviated condition
Time frame: The proportion of subjects who achieved remission after infusion and who received HSCT. (Follow-up monitoring was conducted until 3 years after the infusion)
Overall Survival,(OS）
Time frame: The time from the first infusion of CAR-T cells to death due to any cause (Follow-up monitoring was conducted until 3 years after the infusion)
Negative rate of Minimal Residual Disease（MRD）
Time frame: 28 days after the Sup19 CAR-T infusion

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 20 Apr 2026.
Individual participant dataSharing planned: Undecided

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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.

wangying PI contact

15900225626

wangying1@ihcams.ac.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 20 Apr 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?

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 wangying PI (15900225626, wangying1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation of Sup19 CAR-T cell therapy in patients with hematologic malignancies who have failed prior CD19-targeted therapy or exhibit weak CD19 expression: dose-limiting toxicity (DLT) adverse events (with particular focus on CRS and ICANS) (time frame: up to 28 after CAR-T cell infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539610.

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 Apr 2026.