Acute T Cell Lymphoblastic LeukemiaPhase 1NCT07784309

A Clinical Study of HY035 Cell Injection in the Treatment of CD7-positive Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing HY035 cell injection in people with Acute T Cell Lymphoblastic Leukemia and Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY035 cell injection in the treatment of patients with CD7-positive relapsed or refractory hematologic malignancies. Read more about this study

Who is it for?: Ages 3 to 70 years
Conditions the study is for: Acute T Cell Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory, Acute Myeloid Leukemia (AML)
What is being tested?: HY035 cell injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteChina
Study dates: 15 Aug 2026to 1 Jun 2030
Phase: Phase 1

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 3 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who voluntarily signs the informed consent form;
Age 3 and 70 years, any gender;
Diagnosed with CD7-positive refractory or relapsed hematologic malignancies (including acute T-lymphoblastic leukemia/lymphoblastic lymphoma, acute myeloid leukemia, NK- or T-cell-derived non-Hodgkin lymphoma, etc.);
By flow cytometry, tumor cells expressing CD7 account for ≥80%; or confirmed by immunohistochemistry, tumor cells expressing CD7 account for ≥30%;
During the screening period, acute T lymphoblastic leukemia/lymphoblastic lymphoma and acute myeloid leukemia must meet the requirement that the proportion of bone marrow blasts and immature lymphocytes is ≥5%; extramedullary lesions or non-Hodgkin lymphoma must have measurable lesions on imaging: the longest diameter of nodal lesions must be greater than 1.5 cm, and the longest diameter of extranodal lesions must be greater than 1.0 cm (see "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification").
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 or Lansky/Karnofsky performance score≥60;

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Adequate organ function, meeting the following criteria (except for liver function abnormalities caused by tumor infiltration):
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN);
Total serum bilirubin ≤ 2 × ULN, unless accompanied by Gilbert's syndrome; patients with Gilbert's syndrome can be included if total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN.
Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min/1.73 m² (Cockcroft and Gault formula);
Minimum pulmonary reserve, defined as ≤ grade 1 dyspnea and blood oxygen saturation > 91% without supplemental oxygen;
International normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
The subjects whose partners are fertile agree to use effective contraceptive measures throughout the treatment period and for 24 months after the treatment, and during this period, they are not allowed to donate eggs/sperm for assisted reproduction. Female subjects of childbearing age (women who have undergone sterilization surgery or have been menopausal for ≥12 months are not considered fertile) have negative urine pregnancy or blood pregnancy tests during the screening period.
Willing to undergo hematopoietic stem cell transplantation.

Who cannot join

Patients with active central nervous system (CNS) leukemia or CNS involvement of lymphoma (CNS-3 as defined by NCCN guidelines, or CNS-2 with neurological symptoms), and without other active central nervous system diseases (such as epilepsy, cerebrovascular disease, etc.) or psychiatric disorders; (patients with CNS disease symptoms must undergo lumbar puncture and MRI to rule out CNS infiltration).
Patients with genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
Patients who had acute graft-versus-host disease (GvHD) or moderate to severe extensive chronic GvHD within 4 weeks prior to screening.
Pregnant or breastfeeding women.
Active systemic autoimmune diseases or connective tissue diseases;
Active bleeding;

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Concurrent active infection during the screening period (such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis) that requires treatment;
Positive hepatitis B surface antigen (HBsAg) or detectable HBV DNA, positive hepatitis C antibody (HCV-Ab), positive syphilis treponemal antibody (TP-Ab), positive HIV antibody; EBV DNA or CMV DNA above the detection limit, meeting any one of these criteria.
Major surgery within 4 weeks prior to screening, deemed unsuitable for enrollment by the investigator.
History of or current other malignancies within the past five years, except for tumors with negligible risk of metastasis or death and considered curable, such as adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, etc.
The patient's cardiovascular system meets any of the following conditions:
Left ventricular ejection fraction (LVEF) ≤45% (ECHO);
New York Heart Association (NYHA) class III or IV congestive heart failure;
Serious arrhythmias requiring treatment, including QTc interval ≥480 ms (QTcB = QT/RR^1/2);
Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg), pulmonary hypertension, or unstable angina;
History of myocardial infarction or coronary artery bypass grafting/stent placement within 12 months prior to administration;
Clinically significant valvular disease;
Other cardiac conditions deemed unsuitable for enrollment by the investigator.
Presence of clinically significant pleural effusion, pericardial effusion, or ascites during screening;
Known hypersensitivity to any component of the study drug;
Vaccination with live vaccines within 6 weeks prior to screening;
Previous treatment with anti-CD7 therapy;
Expected life expectancy of less than 3 months;
History of solid organ transplantation;
Participation in other interventional clinical studies within 1 month prior to cell reinfusion, receipt of active investigational drug treatment, or intentional participation in another clinical trial or receiving antitumor treatment not specified in the protocol during the study;
Other situations deemed by the investigator as unsuitable for participation in this clinical 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

Institute of Hematology & Blood Diseases Hospital
Tianjin, 300000

Other trials in China

About this study

Official title: A Clinical Study on the Safety and Efficacy of HY035 Cell Injection in the Treatment of CD7-positive Relapsed or Refractory Hematologic Malignancies

Conditions: Acute T Cell Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory, Acute Myeloid Leukemia (AML), T Cell Lymphoma
Being tested: HY035 cell injection
Medical subject headings: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Leukemia, Myeloid, Acute, Lymphoma, T-Cell

What participants receive

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

HY035 cell injectionDrug
Subjects will receive HY035 cell injection per different dose level

Study groups in NCT07784309
Study group	Role	What they receive
Subjects diagnosed with CD7 positive hematological malignancies	Experimental	Not described Receives: Drug: HY035 cell injection

What is being measured

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

composite complete remission rate and overall remission rate
Measured: at 3 month after infusion
composite complete remission and overall remission rate
Measured: at 3 month after infusion

Secondary outcomes (8)

composite complete remission rate and overall remission rate
Measured: with 6 month after infusion
Best Overall Response
Measured: up to 12 months post-infusion
Duration of Remission
Measured: up to 12 months post-infusion
Time to remission
Measured: up to 12 months post-infusion
Progression Free Survival
Measured: up to 12 months post-infusion
Leukemia-free survival
Measured: up to 12 months post-infusion
Overall Survival, OS
Measured: up to 12 months post-infusion
Hematopoietic stem cell transplantation rate
Measured: up to 12 months post-infusion

Timeline

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

15 Aug 20261 Jun 2030

First posted25 Aug 2026
Study start15 Aug 2026 (estimated)
Primary completion1 Jun 2029 (estimated)
Study completion1 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 T Cell Lymphoblastic 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: 13 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07784309
Sponsor's protocol ID: XJS-IIT2026007
Status last verified: Aug 2026
First submitted: 5 Aug 2026
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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