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

NCT07784309 | Enrolling By Invitation Phase 1

• 1 other identifier: XJS-IIT2026007
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute T Cell Lymphoblastic Leukemia; Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory; Acute Myeloid Leukemia (AML); T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• composite complete remission rate and overall remission rate

  at 3 month after infusion

• composite complete remission and overall remission rate

  at 3 month after infusion

Secondary Outcomes (8)

• composite complete remission rate and overall remission rate

  with 6 month after infusion

• Best Overall Response

  up to 12 months post-infusion

• Duration of Remission

  up to 12 months post-infusion

• Time to remission

  up to 12 months post-infusion

• Progression Free Survival

  up to 12 months post-infusion

Study Arms (1)

Subjects diagnosed with CD7 positive hematological malignancies

EXPERIMENTAL

Drug: HY035 cell injection

Interventions

HY035 cell injection DRUG

Subjects will receive HY035 cell injection per different dose level

Subjects diagnosed with CD7 positive hematological malignancies

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia; Leukemia, Myeloid, Acute; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma, Non-Hodgkin; Lymphoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 25, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)