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T Lymphoblastic Leukemia/LymphomaPhase 1NCT05290155

Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies

A Phase 1 study testing anti-CD7 CAR-T cells in people with T Lymphoblastic Leukemia/Lymphoma and T-cell Acute Lymphoblastic Leukemia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies Read more about this study

Who is it for?
Ages 14 to 70 years
What is being tested?
anti-CD7 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteChina
Study dates
4 May 2022to 1 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Fourteen to 70 Years Old, Male and female;
  • Expected survival > 12 weeks; ECOG score 0-2;
  • Confirmed diagnosis of acute T cell leukemia and screened for CD7 positive,including following conditions:a. Patients who do not get a CR with ≥2 prior induction therapy b. Those who achieves CR, but have a early relapse(<12months),or a late relapse (>=12months) failing to acheive a CR after re-induction chemotherapy c. For any Patiens failed ASCT/allo-SCT
  • Relapsed and refractory patients with diagnosis of CD7 positive T cell lymphoma have had≥2 prior lines of therapy,who do not acheive at least a PR, or have a relapse including:a. Peripheral T cell lymphoma NOS, or b.Angioimmunoblastic T cell lymphoma,or c. Anaplastic large cell lymphoma c.Disease can be assessed(BM or CT scan)
  • Confirmed T lymphoblastic lymphoma：a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients failing to achieve a CR after 1 line salvage chemotherapy c. For any Patients failed ASCT/allo-SCT .Disease can be assessed(BM or CT scan)
  • The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
  • Liver, kidney and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c.Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN;
  • Able to understand and sign the Informed Consent

Who cannot join

  • Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
  • Uncontrolled infection including bacteral or virus or fugal disease;patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection ;HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive;
  • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening),myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia,liver, kidney, or metabolic disease;
  • Any uncontrolled disease may affect entry
  • Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
  • Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
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  • Subjects treated with anti-PD1 or anti-PDL1 therapies within 3months before enrollment
  • Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion;
  • Active or uncontrollable infection requiring systemic therapy Received CAR-T treatment or other gene therapies before enrollment;
  • Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide)
  • The investigators consider other conditions unsuitable for enrollment.
  • Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xianmin General Song

    Shanghai

Other trials in China

About this study

Official title: The Safety and Clinical Efficacy of Human CD7 CAR-T Cell Therapy for Patients With Relapsed/Refractory CD7 Positive T Cell Hematological Maliganacies

The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies

Read the detailed description

This study is single-armed，open lable，dose escalation clinical trial.The main purpose is to evaluate the safety and efficacy of anti-CD7 CAR-T cells in relapsed/refractory patients with CD7 positive T cell malignancies,including T lymphoblastic lymphoma/leukemia ,T-cell non-Hodgkin lymphoma(peripheral T cell lymphoma,NOS,angioimmunoblastic T cell lymphoma and anaplastic large cell lymphoma).There will be three CAR T cell dose groups:0.25*10^6 cells per kilogram of body weight;0.5*10^6 cells per kilogram of body weight，1 *10^6 ells per kilogram of body weight.

Being tested
anti-CD7 CAR-T cells
Keywords
chimeric antigen receptor T cell, T lymphoblastic lymphoma/leukemia, T cell non-Hodgkin lymphoma, CD7
Medical subject headings
Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Peripheral, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Leukemia, Lymphoma, T-Cell

What participants receive

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

  • anti-CD7 CAR-T cellsDrug

    Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients

Study groups in NCT05290155
Study groupRoleWhat they receive
Anti-CD7 CAR T cellsExperimentalAdministration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients
Receives: Drug: anti-CD7 CAR-T cells

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events

    The occurence of study related adverse effects defined by NCI CTCAE5.0

    Measured: 28 days post infusion

Secondary outcomes (7)

  1. CAR-T cell expansion

    Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell expansion after infusion

    Measured: 2 years post infusion

  2. CAR-T cell persistence

    Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell persistence after infusion

    Measured: 2 years post infusion

  3. Number of CD7+ lymphocytes of peripheral blood

    To evaluate CD7 positive cells of peripheral blood after infusion

    Measured: 2 years post infusion

  4. Total response rate (ORR) after administration

    CR+CRi for T-ALL ;CR+PR for T cell lyphoma and T lymphoblastic lymphoma

    Measured: 3 months post infusion

  5. Duration of remission (DOR) after administration

    Duration of remission (DOR) after administration

    Measured: 2 years post infusion

  6. Overall survival(OS) after administration

    Overall Survival (OS)after administration

    Measured: 2 years post infusion

  7. Progression Free Survival (PFS) after administration

    Progression Free Survival (PFS) after administration

    Measured: 2 years post infusion

Timeline

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

  1. First posted22 Mar 2022
  2. Study start4 May 2022
  3. Primary completion1 Aug 2024
  4. Study completion1 May 2025

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290155
Sponsor's protocol ID
SHYSXY-202105-CD7-CART
Status last verified
Jun 2025
First submitted
9 Mar 2022
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD7 CAR-T cells in people with T Lymphoblastic Leukemia/Lymphoma and T-cell Acute Lymphoblastic Leukemia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 8 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: finished, as of the sponsor's last update on 6 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Treatment-Emergent Adverse Events (time frame: 28 days post infusion). 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 NCT05290155.

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 Jun 2025.

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