AzTrials
AzTrials

T Lymphoblastic Leukemia/LymphomaPhase 1NCT04480788

CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study

A Phase 1 study testing T cell injection targeting CD7 chimeric antigen receptor in people with T Lymphoblastic Leukemia/Lymphoma and Extramedullary NK-T-cell Lymphoma, Nasal Type, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients, so as to explore the clinical… Read more about this study

Who is it for?
Ages 7 to 70 years
What is being tested?
T cell injection targeting CD7 chimeric antigen receptor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
24 Nov 2020to 31 Aug 2022
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 7 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The age ranged from 7 to 70 years (including the cut-off value), regardless of gender
  • The expected survival time was more than 6 weeks
  • ECOG score 0-1
  • Malignant lymphoma (including but not limited to acute T-lymphoblastic leukemia / lymphoma; extramedullary NK / T-cell lymphoma, nasal type; peripheral T-cell lymphoma, nonspecific; vascular immunoblastic T-cell lymphoma; intestinal disease associated T-cell lymphomas; anaplastic large cell lymphoma (ALK -); T-cell lymphoblastic leukemia)
  • When screening, hematological malignancies with CD7 Positive confirmed by bone marrow examination or tumor pathology with positive rate of CD7 ≥ 30%, meeting one of the following conditions:
  • At least two chemotherapy regimens failed or did not achieve complete remission or relapse;
Show all 14Show fewer
  • Patients who relapsed after stem cell transplantation were not affected by other treatment methods;
  • For peripheral blood involved acute T-lymphoblastic leukemia / lymphoma and NK / T-cell lymphoma, patients with TCR rearrangement were detected by ngs
  • The liver and kidney function, heart and lung function meet the following requirements:
  • Creatinine ≤ 1.5 ULN;
  • LVEF ≥ 45%;
  • Blood oxygen saturation > 91%;
  • The total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; the abnormal ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction) can be relaxed to ≤ 5 × ULN;
  • Understand the experiment and have signed the informed consent

Who cannot join

  • Those who need immunosuppressant;
  • For intestinal disease-related T-cell lymphoma, patients with intestinal ulcer or hematochezia were examined by colonoscopy;
  • In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
  • The patients with positive HBsAg or HBcAb and HBV DNA titer in peripheral blood were not within the normal reference value; those with positive anti HCV antibody and positive HCV RNA in peripheral blood; those with HIV antibody positive and cytomegalovirus DNA positive Syphilis was positive;
  • Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
  • Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
Show all 14Show fewer
  • Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
  • Pregnant or lactating women, female subjects planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
  • Patients who had received car-t therapy or other gene modified cell therapy before screening;
  • Subjects who were receiving systemic steroid therapy or were receiving systemic steroid therapy for 7 days were excluded;
  • Participated in other clinical studies within 3 months before screening;
  • There was evidence of central nervous system invasion during screening;
  • According to the judgment of the researchers, it does not conform to the condition of cell preparation;
  • Other researchers think it is not suitable to be included in the study.

Trial locations and contacts

1 site in 1 country.

Mingzhi Zhang, Doctor contact

+8613838565629

mingzhi_zhang@126.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Mingzhi Zhang, doctor, +8613838565629, mingzhi_zhang@126.com

    Recruiting

Other trials in China

About this study

Official title: Early Clinical Study on Increasing Dose and Open Label of T Cell Injection Targeting CD7 Autologous Chimeric Antigen Receptor in the Treatment of Relapsed / Refractory CD7 Positive Hemolymph System Malignancies

Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients, so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the increase of their dose may be accompanied by the increase of toxicity, rather than necessary for therapeutic effect, it is not necessarily suitable to recommend the effective dose according to the maximum tolerable dose (MTD). Therefore, this study will be based on the safety data, as well as the preliminary efficacy, efficacy and drug The end point of pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t cells) were comprehensively considered to determine the recommended dose for phase II clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of relapsed / refractory CD7 Positive hematological and lymphoid malignancies.

Being tested
T cell injection targeting CD7 chimeric antigen receptor
Medical subject headings
Lymphoma, Lymphoma, T-Cell, Peripheral, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, Large-Cell, Anaplastic

What participants receive

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

  • T cell injection targeting CD7 chimeric antigen receptorBiological

    Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation

Study groups in NCT04480788
Study groupRoleWhat they receive
T cell injection targeting CD7 chimeric antigen receptorExperimentalNot described
Receives: Biological: T cell injection targeting CD7 chimeric antigen receptor

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Safety results

    Number of adverse events

    Measured: Up to 2 years

  2. PK

    The maximum concentration (Cmax）

    Measured: Up to 2 years

  3. PK

    the time to reach the maximum concentration (Tmax)

    Measured: Up to 2 years

  4. PK

    The area under the curve (auc0-28d ) at 28d respectively after administration

    Measured: Up to 2 years

  5. PD

    Absolute value of CD7 Positive Cells in peripheral blood at each time point

    Measured: Up to 2 years

  6. PD

    The proportion of CD7 Positive Cells in peripheral blood at each time point

    Measured: Up to 2 years

  7. ORR

    The total response rate was 3 months and 6 months

    Measured: Up to 2 years

  8. overall survival (OS)

    Time from initiation of CD7 car-t cell therapy to death (for any reason)

    Measured: Up to 2 years

  9. Search Results Featured snippet from the web Duration of response (DOR)

    The time from the first assessment of Cr or PR to the first assessment of recurrence or progression of the disease or death from any cause

    Measured: Up to 2 years

  10. Progression-free survival (PFS)

    The time from the beginning of treatment with CD7 car-t cells to the first progression of disease or death from any cause

    Measured: Up to 2 years

  11. Immunogenicity

    The positive rate of human anti car antibody at each time point

    Measured: Up to 2 years

Timeline

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

  1. First posted21 Jul 2020
  2. Study start24 Nov 2020
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion31 Aug 2022 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
CD7-CART
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480788
Sponsor's protocol ID
PG-CART-07-001
Status last verified
Jan 2021
First submitted
14 Jul 2020
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T cell injection targeting CD7 chimeric antigen receptor in people with T Lymphoblastic Leukemia/Lymphoma and Extramedullary NK-T-cell Lymphoma, Nasal Type, run by PersonGen BioTherapeutics (Suzhou) Co., 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 14 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: status not confirmed, as of the sponsor's last update on 6 Jan 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mingzhi Zhang, Doctor (+8613838565629, mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Up to 2 years). 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 NCT04480788.

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 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in