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AzTrials

T-cell Acute Lymphoblastic Leukemia/LymphomaPhase 1NCT04572308

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells

A Phase 1 study testing CD7 CAR-T in people with T-cell Acute Lymphoblastic Leukemia/Lymphoma, 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 relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (TLBL). Read more about this study

Who is it for?
Ages 2 to 65 years
What is being tested?
CD7 CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Oct 2020to 30 May 2021
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 2 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. 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-positive tumor (≥70% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors burden >5%,or MRD+， or new extramedullary lesions reappeared.
  • Life expectancy greater than 12 weeks
  • KPS or Lansky score≥60
  • HGB≥70g/L
  • 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；
  • Presence of 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 to 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 any symtomatic CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
  • Received allogeneic hematopoietic stem cell transplantation within 6 months;
  • 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

  • Hebei yanda Ludaopei Hospital

    Yanda, Hebei

Other trials in China

About this study

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (TLBL).

Read the detailed description

The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, 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 relapsed or refractory T-ALL/LBL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with relapsed or refractory T-ALL/LBL

Being tested
CD7 CAR-T
Keywords
T-ALL，T-LBL , CD7，CAR-T
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma

What participants receive

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

  • CD7 CAR-TBiological

    Patients will be treated with CD7 CAR-T cells

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

Study groups in NCT04572308
Study groupRoleWhat they receive
CD7 CAR-TExperimentalPatients will be treated with CD7 CAR-T cells
Receives: Biological: CD7 CAR-T

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 the 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

    Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR)

    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: Long time

  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 posted1 Oct 2020
  2. Study start1 Oct 2020
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572308
Sponsor's protocol ID
CD7 CAR-T for T-ALL/T-LBL
Status last verified
Jun 2021
First submitted
27 Sep 2020
Last updated
29 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cao XY, Zhang JP, Wei ZJ, Lu Y, Zhao YL, Xiong M, Zhou JR, Wang Y, Yang JF, Zhang X, Li J, Lu P. Long-Term Outcomes of Second Allogeneic Transplantation Following CD7 CAR-T in Remission for T-Cell Acute Lymphoblastic Leukemia or Lymphoma. Transplant Cell Ther. 2026 Aug;32(8):956.e1-956.e13. doi: 10.1016/j.jtct.2026.05.045. Epub 2026 Jun 1.

    PubMed 42229585

  • Velasquez MP. Allogeneic CD7-CAR T cells to bridge the gap? Transplant Cell Ther. 2023 Mar;29(3):139-140. doi: 10.1016/j.jtct.2023.02.006. No abstract available.

    PubMed 36858787

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD7 CAR-T in people with T-cell Acute Lymphoblastic Leukemia/Lymphoma, 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 29 Jun 2021. 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?

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 NCT04572308, which also lists 2 linked publications.

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 29 Jun 2021.

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