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Solid Tumor, AdultPhase 1NCT04556669

Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors

A Phase 1 study testing Autologous aPD-L1 armored anti-CD22 CAR T cells in people with Solid Tumor, Adult and Cervical Cancer, run by Hebei Senlang Biotechnology Inc., 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is an open-labeled, single-armed and prospective study, patients with advanced malignant solid tumors will be given with SL22P autologous CAR - T/CAR-TILs cells. The aim of the study is to evaluate the safety and efficacy of SL22P CAR-T cells, including the adverse reaction, pharmacokinetics, and the outcomes of… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Adult, Cervical Cancer, Sarcoma
What is being tested?
Autologous aPD-L1 armored anti-CD22 CAR T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Aug 2020to 1 Aug 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be enrolled, subjects must meet all the following conditions:
  • Volunteer to participate in the clinical study, cooperate with the researcher to carry out the research, and sign the informed consent.
  • 18-75 years old (including boundary value), male or female;
  • Life expectancy ≥ 12 weeks;
  • Patients with ECOG score less than 2
  • All acute toxicity from prior antitumor therapy or surgery is reduced to level 0 to 2.
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  • Patients with at least one measurable tumor focus according to recist1.1 standard;
  • Patients with advanced malignant solid tumors who still have disease progression under standard treatment, are intolerant to standard treatments, or lack effective standard treatments, and are pathologically confirmed;
  • Sufficient organ and bone marrow function, defined as follows:
  • Neutrophil count (ANC) ≥ 1,500/mm3(1.5 × 109/L); B) Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L); C) Hemoglobin (Hb) ≥ 9 g/dL (90 g/L); D) Serum albumin ≥ 2.8g /dL; E) Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 50 ml/min; F) Total bilirubin (BIL) ≤ 1.5×ULN, patients with liver metastasis or liver cancer ≤2×ULN; G) AST/SGOT or ALT/SGPT ≤ 2.5×ULN, patients with liver metastasis or liver cancer ≤ 5×ULN; H) International standardized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤ 1.5×ULN.
  • Patients with asymptomatic central nervous system (Central Nervous System, CNS) metastasis, or asymptomatic brain metastases after treatment, must be checked by computed tomography (CT) or magnetic resonance imaging (MRI) without disease progression, stable at least 3 Steroid medication is not required for at least 4 weeks..
  • Male patients and female patients of childbearing age should agree to take effective contraceptive measures from the signing of the informed consent form until 3 months after the last dose.

Who cannot join

  • Prior therapy with PD-L1 inhibitors
  • Prior therapy as follow:
  • major surgery within 28 days prior to the first study drug treatment (biopsy required for diagnosis is permitted).
  • Systemic therapy with immunosuppressive agents within 14 days before the first autologous of study drug, nasal spray and inhaled corticosteroids or physiological doses of steroid hormones are NOT excluded C) Vaccination with live attenuated vaccine within 28 days before the first study drug treatment or planned during the study period and 60 days after the end of the study drug treatment
  • With uncontrollable or symptomatic active central nervous system (CNS) metastasis. Patients with a history of CNS metastasis or spinal cord compression, but if the patient determined to have it stopped by using anticonvulsants and steroids before the first administration and could be clinically stable four weeks later, they may be enrolled in the study.
  • Patients with advanced symptoms, spread to the internal organs, or risk of life-threatening complications in a short-term (including patients with uncontrolled exudate [chest, pericardium, abdominal cavity]).
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  • Have any active autoimmune disease or have a history of autoimmune disease and expected recurrence.
  • Patients with skin diseases that require no systemic treatment, such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma that have been completely alleviated and may be included without any intervention as adults; Asthmatics required medical intervention with bronchodilators are excluded.
  • Had other active malignant tumors within 2 years before entering the study. Skin basal cell that can be treated topically and cured or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid were excluded
  • Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection;
  • Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina by New York Heart Association Patients with grade 2 or higher cardiac insufficiency and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
  • Severe infection with no effective control.
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known.
  • Participated in any other drug clinical study within 4 weeks before the first administration, or no more than 5 half-lives before the last study.
  • A history of substance abuse or drug abuse is known.
  • The presence of other serious physical or mental illness or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the results of the study, as well as patients whom the investigator deems inappropriate for participating in the study.
  • Note: Severe infection refers to sepsis or uncontrolled infection, which can be included in the group only after infection.
  • Exit criteria :
  • Withdrawal: This can be divided into investigator performed withdrawal and patient 's voluntary withdrawal from the clinical trial
  • Withdrawal implemented by the investigator: When the patients meets the suspension criteria specified in the protocol during the trial, such as: vital organ dysfunction, drug allergic reaction, poor compliance, worsening of the disease, or serious adverse reactions, it is necessary to stop the trial drug treatment or adopt other treatment methods During treatment, the researcher asked the patients to withdraw from the trial. Due to the differences of patients ' cells, there was a possibility that insufficient number of CAR-T cell can't be prepared.Thus, the investigator judges that the patient needs to withdraw from the study.
  • Patient's withdrawal: such as poor efficacy, intolerance of adverse reactions, hope to adopt other treatment methods, or voluntarily withdraw from the trial without any reason

Trial locations and contacts

1 site in 1 country.

Zhimeng Qiu contact

15511635920

qiuzhimeng@senlangbio.com

China1 site, 1 recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Zhiyu Wang, PhD & MD, cpucjz@163.com

    Jianqiang Li, PhD & MD, limmune@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Feasibility and Safety of Anti-PD-L1 Armored Anti-CD22 CAR-T/CAR-TILs Targeting Patients With Solid Tumors

This is an open-labeled, single-armed and prospective study, patients with advanced malignant solid tumors will be given with SL22P autologous CAR - T/CAR-TILs cells. The aim of the study is to evaluate the safety and efficacy of SL22P CAR-T cells, including the adverse reaction, pharmacokinetics, and the outcomes of patients.

Read the detailed description

SL22P is a proprietary product of Senlang Biotechnology. The T cells may be isolated from the peripheral blood or from the tumor tissue. The CAR-T/CAR-TILs cells contains a anti-CD22 CAR structure and also carries a scFv fragment of anti-PD-L1 monoclonal antibody. After autologous SL22P CAR-T/CAR-TILs cells were transplanted back into patients, CAR-T would target CD22+B cells in the blood. This will promote the activation and amplification of CAR+ cells, and secrete anti-PD-L1 scFv outside the cells to regulate the immunity and enhance anti-tumor activity. The CAR-TILs may reduce the severity of the adverse reactions than conventional TILs, which result from the combination of high dose IL-2 infusion.

Being tested
Autologous aPD-L1 armored anti-CD22 CAR T cells
Keywords
CD22, chimeric antigen receptor, solid tumor, tumor infiltration lymphocyte
Medical subject headings
Uterine Cervical Neoplasms, Sarcoma

What participants receive

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

  • Autologous aPD-L1 armored anti-CD22 CAR T cellsBiological

    Autologous aPD-L1 armored CD22-targeting CAR T cells

Study groups in NCT04556669
Study groupRoleWhat they receive
CD22（aPD-L1）CAR-T cellsExperimentalNot described
Receives: Biological: Autologous aPD-L1 armored anti-CD22 CAR T cells

What is being measured

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

  1. safety evaluation

    To evaluate the possible adverse reactions recorded within 3 months after SL22P infusion, mainly including the incidence, incidence and severity of skin toxicity, organ toxicity, severe neurotoxicity, cytokine storm and other immunotherapy related toxic reactions (irAEs).

    Measured: first three months

Secondary outcomes (6)

  1. Tmax of cell metabolism

    The highest concentration (Cmax) of anti-CD22 CAR-T cells amplified in peripheral blood; the time to reach the highest concentration (Tmax).

    Measured: first month

  2. The AUC28d of cell metabolism

    The according area under the curve at 28 days (AUC28d).

    Measured: first month

  3. PFS evaluation

    The researchers evaluated progression-free survival (PFS) according to RECIST V1.1.

    Measured: 12 months

  4. OS evaluation

    The researchers evaluated overall survival (OS) according to RECIST V1.1.

    Measured: 12 months

  5. ORR evaluation

    The researchers evaluated objective remission rate (ORR) according to RECIST V1.1.

    Measured: 12 months

  6. DoR evaluation

    The researchers evaluated remission duration (DoR) according to RECIST V1.1.

    Measured: 12 months

Timeline

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

  1. First posted21 Sep 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Aug 2025 (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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556669
Sponsor's protocol ID
Senl_C22P CAR-T/CAR-TIL
Status last verified
May 2021
First submitted
6 Sep 2020
Last updated
27 May 2021
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 Autologous aPD-L1 armored anti-CD22 CAR T cells in people with Solid Tumor, Adult and Cervical Cancer, 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 12 inclusion and 21 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 27 May 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 Zhimeng Qiu (15511635920, qiuzhimeng@senlangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety evaluation (time frame: first three months). 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 NCT04556669.

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 27 May 2021.

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