CD7-Positive Hematological MalignanciesNCT07345780
Clinical Study on the Safety and Efficacy of CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
A study testing CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies in people with CD7-Positive Hematological Malignancies, run by Donghua Zhang at 1 site in China.
Trial summary
This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- CD7-Positive Hematological Malignancies
- What is being tested?
- CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2026to 31 Dec 2029
- Phase
- Interventional
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.
- Aged 18-85 years (inclusive), gender not restricted. Subjects diagnosed according to WHO 2016 criteria with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early T-precursor lymphoblastic leukemia) who have failed standard treatment or lack effective treatment options, meeting any of the following criteria:a) Relapsed: Previously received at least two treatment regimens and achieved complete remission followed by confirmed disease recurrence, or achieved complete remission after stem cell transplantation followed by disease recurrence.b) Refractory: Previously received at least two treatment regimens and failed to achieve CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to achieve remission or experienced disease progression after stem cell transplantation.
- Diagnosed with AML according to the 2016 WHO classification and meeting the diagnostic criteria for relapsed and refractory AML in the Chinese Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition):a) Diagnostic criteria for relapsed AML: Reappearance of leukemic cells in peripheral blood after complete remission (CR), or >5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary leukemic cell infiltration.b) Diagnostic criteria for refractory AML: Newly diagnosed cases failing to respond to standard treatment after 2 courses; Relapse within 12 months after CR following consolidation/intensification therapy; Relapse after 12 months but unresponsive to conventional chemotherapy; Two or more relapses; Persistent extramedullary leukemia.
- Hematolymphoid malignancies confirmed by flow cytometry in bone marrow examination and/or by pathological immunohistochemistry in tumor tissue as CD7-positive at screening, with tumor positivity rate ≥70%.
- Patients who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT) must have the ability to donate autologous mononuclear cells (hereinafter referred to as apheresis) or peripheral blood for CAR-T cell manufacturing. Peripheral blood smear at screening should show <30% tumor cells. For patients who have received allo-HSCT requiring autologous blood collection, peripheral blood smear at screening should also show <30% tumor cells; there is no such restriction if collecting donor blood.
- Patients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade <2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).
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- ECOG performance status score 0-2 and life expectancy >3 months.
- Appropriate organ function:
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3×upper limit of normal (ULN). For ALT and AST abnormalities judged by the investigator to be disease-related (e.g., liver infiltration or biliary obstruction), the limit may be extended to ≤5×ULN.
- Total bilirubin ≤1.5×ULN. Serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min. Hemoglobin ≥60 g/L or maintained at this level after transfusion. Room air oxygen saturation ≥92%. Left ventricular ejection fraction (LVEF) ≥45%. Patients failing to meet any of the above criteria will not be enrolled as subjects.
Who cannot join
- History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.
- Patients with clinically symptomatic central nervous system leukemia. Positive for hepatitis B surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with HBV DNA titer outside the normal reference range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.
- History of severe allergies [severe allergy defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimens).
- Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (defined as: blood pressure not controlled despite ≥3 antihypertensive drugs (including diuretics) at maximum tolerated doses for >1 month after lifestyle modification, or requiring ≥4 antihypertensive drugs for effective control).
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.
- Previous organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).
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- Acute or chronic graft-versus-host disease (GVHD) of any grade occurring 2 weeks after discontinuation of immunosuppressive therapy.
- Hematopoietic stem cell transplantation within 6 months prior to screening. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- Tumor emergencies requiring urgent treatment at screening or prior to infusion (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).
- Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment.
- Major surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds prior to enrollment.
- Live virus vaccination within 4 weeks prior to screening. Severe mental illness. History of alcoholism or substance abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.
- Patients with contraindications to any study procedures or other medical conditions that may put them at unacceptable risk according to investigator judgment and/or clinical standards.
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
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Andie Fu, 15926614832, andie_fu@163.com
About this study
Official title: This Study is a Single-arm, Multicenter Investigator-Initiated Trial (IIT) Clinical Study. The Primary Objective is to Evaluate the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of CAR-T Cells in Subjects With Relapsed/Refractory (r/r) CD7-positive Hematological Malignancies. The Study Plans to Enroll 20 Subjects, With the Actual Sample Size to be Determined Based on Real-world Occurrence.
This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.
- Conditions
- CD7-Positive Hematological Malignancies
- Being tested
- CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological MalignanciesDrug
CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Experimental group | Experimental | Not described Receives: Drug: CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Time frame:1, 3,6,12,18, 24 months after tretment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD7-Positive Hematological MalignanciesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donghua Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donghua Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345780
- Sponsor's protocol ID
- DHZ1962-F
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is a Single-arm, Multicenter Investigator-Initiated Trial (IIT) Clinical Study. The Primary Objective is to Evaluate the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of CAR-T Cells in Subjects With Relapsed/Refractory (r/r) CD7-positive Hematological Malignancies. The Study Plans to Enroll 20 Subjects, With the Actual Sample Size to be Determined Based on Real-world Occurrence.
- ClinicalTrials.gov ID
- NCT07345780
- Acronym / sponsor ID
- DHZ1962-F
- Conditions
- CD7-Positive Hematological Malignancies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Donghua ZhangUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jan 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 a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:Experimental group | Experimental | Drug: CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.
- Aged 18-85 years (inclusive), gender not restricted. Subjects diagnosed according to WHO 2016 criteria with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early T-precursor lymphoblastic leukemia) who have failed standard treatment or lack effective treatment options, meeting any of the following criteria:a) Relapsed: Previously received at least two treatment regimens and achieved complete remission followed by confirmed disease recurrence, or achieved complete remission after stem cell transplantation followed by disease recurrence.b) Refractory: Previously received at least two treatment regimens and failed to achieve CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to achieve remission or experienced disease progression after stem cell transplantation.
- Diagnosed with AML according to the 2016 WHO classification and meeting the diagnostic criteria for relapsed and refractory AML in the Chinese Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition):a) Diagnostic criteria for relapsed AML: Reappearance of leukemic cells in peripheral blood after complete remission (CR), or >5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary leukemic cell infiltration.b) Diagnostic criteria for refractory AML: Newly diagnosed cases failing to respond to standard treatment after 2 courses; Relapse within 12 months after CR following consolidation/intensification therapy; Relapse after 12 months but unresponsive to conventional chemotherapy; Two or more relapses; Persistent extramedullary leukemia.
- Hematolymphoid malignancies confirmed by flow cytometry in bone marrow examination and/or by pathological immunohistochemistry in tumor tissue as CD7-positive at screening, with tumor positivity rate ≥70%.
- Patients who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT) must have the ability to donate autologous mononuclear cells (hereinafter referred to as apheresis) or peripheral blood for CAR-T cell manufacturing. Peripheral blood smear at screening should show <30% tumor cells. For patients who have received allo-HSCT requiring autologous blood collection, peripheral blood smear at screening should also show <30% tumor cells; there is no such restriction if collecting donor blood.
Key exclusion criteria (13 listed)
- History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.
- Patients with clinically symptomatic central nervous system leukemia. Positive for hepatitis B surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with HBV DNA titer outside the normal reference range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.
- History of severe allergies [severe allergy defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimens).
- Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (defined as: blood pressure not controlled despite ≥3 antihypertensive drugs (including diuretics) at maximum tolerated doses for >1 month after lifestyle modification, or requiring ≥4 antihypertensive drugs for effective control).
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.
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-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological MalignanciesCD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies | Drug | Experimental:Experimental group |
Primary outcome
Overall survival
Time frame: Time frame:1, 3,6,12,18, 24 months after tretment
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 16 Jan 2026.
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Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
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A Clinical Study of HY035 Cell Injection in the Treatment of CD7-positive Relapsed or Refractory Hematologic Malignancies
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SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
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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.
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies in people with CD7-Positive Hematological Malignancies, run by Donghua Zhang 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 10 inclusion and 13 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 16 Jan 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Time frame:1, 3,6,12,18, 24 months after tretment). 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 16 Jan 2026.