T Lymphoblastic LymphomaEarly Phase 1NCT07476027
Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL
A Early Phase 1 study testing CD7 CAR-T cell intravenous infusion in people with T Lymphoblastic Lymphoma and T Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- T Lymphoblastic Lymphoma, T Acute Lymphoblastic Leukemia
- What is being tested?
- CD7 CAR-T cell intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 27 Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged ≤18 years with newly diagnosed T-LBL/ALL.
- Have completed induction chemotherapy and achieved CR1, with bone marrow MRD < 0.01%.
- High/very high-risk or poor induction response patients.
- High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.
- Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80).
- Legal guardian agrees to provide written informed consent.
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- Infusion Criteria:
- Essential normal function of major organs.
- Left ventricular ejection fraction (LVEF) ≥ 45%.
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age.
- Serum total bilirubin, ALT/AST ≤ 3 × ULN (unless clearly related to leukemic infiltration).
- No active, uncontrolled severe infection.
Who cannot join
- Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
- Complicated with other progressive malignant tumors.
- Presence of active and/or uncontrolled infections that have not been effectively managed.
- Complicated with severe autoimmune diseases or congenital immunodeficiency.
- Active hepatitis [positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center].
- Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.).
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- A history of severe hypersensitivity to biological products (including antibiotics).
- Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
- Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.
About this study
Official title: Efficacy and Safety of CD7 CAR-T Cell in Newly Diagnosed High-Risk T-LBL/ALL
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.
- Being tested
- CD7 CAR-T cell intravenous infusion
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CAR-T cell intravenous infusionBiological
CD7 CAR-T cells, single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CD7 CAR-T cell injection | Experimental | Not described Receives: Biological: CD7 CAR-T cell intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR Rate
CR+CRi
Measured: 28 days after CD7 CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion27 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Lymphoblastic LymphomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476027
- Sponsor's protocol ID
- IIT2026027
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CD7 CAR-T Cell in Newly Diagnosed High-Risk T-LBL/ALL
- ClinicalTrials.gov ID
- NCT07476027
- Acronym / sponsor ID
- IIT2026027
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 27 Jun 2029 (estimated)
- First posted
- 17 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 study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD7 CAR-T cell injection | Experimental | Biological: CD7 CAR-T cell intravenous infusion |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Patients aged ≤18 years with newly diagnosed T-LBL/ALL.
- Have completed induction chemotherapy and achieved CR1, with bone marrow MRD < 0.01%.
- High/very high-risk or poor induction response patients.
- High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.
- Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80).
Key exclusion criteria (9 listed)
- Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
- Complicated with other progressive malignant tumors.
- Presence of active and/or uncontrolled infections that have not been effectively managed.
- Complicated with severe autoimmune diseases or congenital immunodeficiency.
- Active hepatitis [positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center].
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 |
|---|---|---|
| CD7 CAR-T cell intravenous infusionCD7 CAR-T cells, single intravenous infusion | Biological | CD7 CAR-T cell injection |
Primary outcome
CR Rate
Time frame: 28 days after CD7 CAR-T cell infusion
CR+CRi
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 17 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD7 CAR-T cell intravenous infusion in people with T Lymphoblastic Lymphoma and T Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 12 inclusion and 9 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
CR Rate (time frame: 28 days after CD7 CAR-T cell infusion). 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 17 Mar 2026.