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Leukemia, T CellNCT04938115

Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia

A study testing CD7 CART in people with Leukemia, T Cell, run by Hebei Senlang Biotechnology Inc., Ltd. 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

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL Read more about this study

Who is it for?
Ages 2 to 70 years
Conditions the study is for
Leukemia, T Cell
What is being tested?
CD7 CART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
10 May 2021to 30 Oct 2023
Phase
Interventional
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 2 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of refractory or relapsed CD7+ acute myeloid leukemia or mixed lineage leukemia was made according to the NCCN 2019.V2 guideline. Refractory AML is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed AML is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patient diagnosed with AML should be treated and whose disease failed with at least 2 prior lines of therapies. Patients whose tumor burden ≥5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible;
  • CD7+ expression on tumor cells (CD7 positive blasts ≥50% by flow cytometry);
  • Life expectancy greater than 12 weeks;
  • KPS or Lansky score≥60;
  • HGB≥70g/L (can be transfused);
  • oxygen saturation of blood>90%;
  • Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
  • Informed consent explained to, understood by and signed by patient/guardian

Who cannot join

  • Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
  • Has an active GvHD;
  • Has a history of severe pulmonary function damaging;
  • With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  • Severe or persistent infection that cannot be effectively controlled；
  • Merging severe autoimmune diseases or immunodeficiency disease;
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  • Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
  • Patients with HIV infection or syphilis infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6;
  • Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
  • Have received transplant treatment for less than 6 months in prior to enrollment;
  • Being pregnant and lactating or having pregnancy within 12 months;
  • Any situations that the researchers believe will increase the risks for the subject or affect the results of the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • He bei Yan da Lu dao pei Hospital

    Beijingcun, Hebei

Other trials in China

About this study

Official title: Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Read the detailed description

The CARs consist of an anti-CD7 VHHs, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Being tested
CD7 CART
Medical subject headings
Leukemia, T-Cell

What participants receive

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

  • CD7 CARTBiological

    Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Study groups in NCT04938115
Study groupRoleWhat they receive
CD7 CAR-TExperimentalNot described
Receives: Biological: CD7 CART

What is being measured

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

  1. Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    Measured: First 1 month post CAR-T cells infusion

  2. Efficacy: Remission Rate

    In the presence of extramedullary lesions, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe extramedullary lesions

    Measured: 3 months post CAR-T cells infusion

Secondary outcomes (7)

  1. duration of response (DOR)

    duration of response (DOR)

    Measured: 24 months post CAR-T cells infusion

  2. Efficacy: progression-free survival (PFS)

    progression-free survival (PFS) time

    Measured: 24 months post CAR-T cells infusion

  3. CAR-T proliferation

    the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method

    Measured: 3 months post CAR-T cells infusion

  4. CAR-T proliferation

    percentage of CD7 CAR- T cells measured by flow cytometry method

    Measured: 3 months post CAR-T cells infusion

  5. Cytokine release

    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

    Measured: First 1 month post CAR-T cells infusion

  6. Pharmacokinetics (PK) indicators

    the peak concentration of Senl-T7 CAR-T cells amplified in the peripheral blood (Cmax, detected by flow cytometry and qPCR); the time taken to reach the peak concentration (Tmax), and the persistent time of the Senl-T7 CAR-T cells in vivo in patients

    Measured: 24 months post CAR-T cells infusion

  7. Pharmacodynamic (PD) indicators

    the pharmacodynamic change in the clearance of peripheral blood CD7+ cells and the release of the cytokines at each observation time point

    Measured: First 1 month post CAR-T cells infusion

Timeline

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

  1. First posted24 Jun 2021
  2. Study start10 May 2021
  3. Primary completion31 May 2023
  4. Study completion30 Oct 2023

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938115
Sponsor's protocol ID
CD7+ mixed lineage leukemia
Status last verified
May 2023
First submitted
16 Jun 2021
Last updated
14 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lu P, Zhang X, Yang J, Li J, Qiu L, Gong M, Wang H, Chen J, Liu H, Xiong M, Liu Y, Wang L. Nanobody-based naturally selected CD7-targeted CAR-T therapy for acute myeloid leukemia. Blood. 2025 Mar 6;145(10):1022-1033. doi: 10.1182/blood.2024024861.

    PubMed 39561281

Questions about this trial

What is this clinical trial studying?

A study testing CD7 CART in people with Leukemia, T Cell, run by Hebei Senlang Biotechnology Inc., Ltd. 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 14 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 14 Jun 2024. 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?

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?

Safety: Incidence and severity of adverse events (time frame: First 1 month post CAR-T cells infusion). 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 NCT04938115, which also lists 1 linked publication.

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 14 Jun 2024.

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