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CD7 PositivePhase 2NCT07106723

Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL

A Phase 2 study testing ASCT+CD7-CART in people with CD7 Positive and T - Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
CD7 Positive, T - Cell Lymphoma
What is being tested?
ASCT+CD7-CART
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Jun 2025to 7 Jan 2030
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • With the subject's consent and having signed the informed consent form, willing and capable of adhering to the planned visits, study treatment, laboratory tests and other trial procedures;
  • Age 18 to 65 years old, both male and female;
  • Confirmed as T-cell non-Hodgkin's lymphoma type (including T-lymphoblastic lymphoma/leukemia) according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022), and meeting one of the following three conditions: 1) Newly diagnosed with high-risk factors, such as Ann Arbor stage III/IV, large mass, bone marrow invasion, central nervous system (CNS) invasion, ETP phenotype, RAS activating mutation, TP53 deletion/mutation, etc., as assessed by the investigator; 2) Not achieving PR or better response after induction and consolidation therapy; 3) Patients not considered for allogeneic hematopoietic stem cell transplantation;
  • Confirmed as tumor cells expressing CD7 by histopathology and/or cytology at the time of screening;
  • With appropriate organ function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), if the investigator determines that the abnormal ALT and AST are due to the disease (such as liver infiltration or bile duct obstruction), the indicators can be relaxed to ≤ 5 times ULN; 2) Total serum bilirubin ≤ 2 times ULN, except for patients with Gilbert's syndrome; patients with Gilbert's syndrome and total bilirubin ≤ 3 times ULN and direct bilirubin ≤ 1.5 times ULN can be included; 3) Serum creatinine clearance rate ≥ 30 mL/min; 4) International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN; 5) Possessing the minimum level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and non-oxygen-dependent blood oxygen saturation ≥ 92%; 6) Left ventricular ejection fraction ≥ 50% by echocardiography; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion and pleural effusion.
  • Women of childbearing age have a negative blood/urine pregnancy test within 7 days before infusion. Any male and female patients with fertility must agree to use effective contraceptive methods throughout the study and for at least 2 years after the administration of study treatment.
  • -

Who cannot join

  • Subjects with one or more of the following are not eligible for this study:
  • History of allergy to any of the components in the cell product;
  • Severe cardiac disease, including but not limited to: Myocardial infarction, cardiac angioplasty, or stenting within 6 months prior to signing the ICF; unstable angina; severe cardiac arrhythmias; History of severe non-ischemic cardiomyopathy; Congestive heart failure (New York Heart Association [NYHA] Class III or IV), NYHA score listed in Appendix II
  • Have a history of autologous/allogeneic hematopoietic stem cell transplantation;
  • stroke or seizure within 6 months prior to signing the ICF;
  • Have autoimmune diseases, immunodeficiencies or other diseases that require immunosuppressant treatment;
Show all 12Show fewer
  • Within 3 years prior to signing the ICF, have malignancies other than T-cell hematologic tumors, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, carcinoma in situ of the duct in situ after radical resection, carcinoma in situ of other sites one year after radical resection, and there has been no treatment during the screening period and there is no sign of recurrence;
  • presence of uncontrolled active infection;
  • Unstable systemic diseases judged by the investigator: including but not limited to severe hepatic, renal or metabolic diseases requiring drug treatment;
  • Any of the following within 4 weeks prior to lymphocyte collection:
  • The DNA detection value of hepatitis B virus (HBV) in peripheral blood was higher than the lower limit of detection; Positive for hepatitis C virus (HCV) antibody and positive for peripheral HCV-RNA; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antigen or antibody; Positive for CMV-DNA (10) application of prednisone (or equivalent amounts of other corticosteroids) in excess of 5mg/day within 1 week prior to lymphocyte collection; (11) Have used any CAR-T cell products or other genetically modified T-cell therapies; (12) Received CD7-targeted therapy; (13) History of live vaccination within 4 weeks prior to signing the ICF; (14) Have a history of alcoholism, drug abuse, or mental illness; (15) Other situations that the investigator considers unsuitable to participate in this study.
  • -

Trial locations and contacts

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

Liang Huang, Dr contact

022-23608359

huangliang@ihcams.ac.cn

China1 site, 1 recruiting

  • Blood Disease Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

    Liang Huang, Dr, 022-23608359, huangliang@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Combination With CD7-CART in the Treatment of CD7+ T-Cell Lymphoma

To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL

Being tested
ASCT+CD7-CART
Medical subject headings
Lymphoma, T-Cell

What participants receive

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

  • ASCT+CD7-CARTDrug

    Intravenous infusion of CD7-CART 3 days after ASCT

Study groups in NCT07106723
Study groupRoleWhat they receive
ASCT conbined with CD7-CART.ExperimentalNot described
Receives: Drug: ASCT+CD7-CART

What is being measured

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

  1. PFS rate at 1 year after ASCT conbined with CD7-CART

    Measured: at 1 year after ASCT conbined with CD7-CART

  2. Incidence and Severity of Adverse Events after ASCT conbined with CD7-CART

    Refer to irAE grading standard

    Measured: during 2 years after ASCT conbined with CD7-CART

Secondary outcomes (9)

  1. Duration of Response (DOR)

    Time from first response evaluated by investigator to disease progression or death from any cause

    Measured: during 2 years after ASCT conbined with CD7-CART

  2. Progression-free Survival (PFS)

    Measured: during 2 years after ASCT conbined with CD7-CART

  3. MRD negetive rate

    Measured: at 3 or 6 month after ASCT conbined with CD7-CART

  4. Time to Response (TTR)

    Time from CD7-CART infusion to first documentation of response evaluated by investigators

    Measured: during 2 years after ASCT conbined with CD7-CART

  5. Overall Survival (OS)

    Measured: during 2 years after ASCT conbined with CD7-CART

  6. Cmax

    the peak CARgene copy number in peripheral blood

    Measured: during 3 month after ASCT conbined with CD7-CART

  7. Tmax

    time to reach the peak of CARgene copy number in peripheral blood

    Measured: during 3 month after ASCT conbined with CD7-CART

  8. AUC(0-28d)

    area under curve of CARgene copy number in peripheral blood

    Measured: during 28 days after ASCT conbined with CD7-CART

  9. Tlast

    duration of existence of CARgene copy number in peripheral blood

    Measured: during 1 year after ASCT conbined with CD7-CART

Timeline

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

  1. First posted6 Aug 2025
  2. Study start1 Jun 2025
  3. Primary completion7 Jan 2029 (estimated)
  4. Study completion7 Jan 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
ASCT conbined with CD7-CART
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106723
Sponsor's protocol ID
IIT2025051
Status last verified
Jul 2025
First submitted
30 Jul 2025
Last updated
6 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASCT+CD7-CART in people with CD7 Positive and T - Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Liang Huang, Dr (022-23608359, huangliang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS rate at 1 year after ASCT conbined with CD7-CART (time frame: at 1 year after ASCT conbined with CD7-CART). The study lists 2 primary outcomes in all. 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 NCT07106723.

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 6 Aug 2025.

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