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

NCT04556669 | Unknown Phase 1

• 1 other identifier: Senl_C22P CAR-T/CAR-TIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 patients.

Conditions

Solid Tumor, Adult; Cervical Cancer; Sarcoma; NSCLC

Keywords

CD22; chimeric antigen receptor; solid tumor; tumor infiltration lymphocyte

Outcome Measures

Primary Outcomes (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).

  first three months

Secondary Outcomes (6)

• Tmax of cell metabolism

  first month

• The AUC28d of cell metabolism

  first month

• PFS evaluation

  12 months

• OS evaluation

  12 months

• ORR evaluation

  12 months

Study Arms (1)

CD22（aPD-L1）CAR-T cells

EXPERIMENTAL

Biological: Autologous aPD-L1 armored anti-CD22 CAR T cells

Interventions

Autologous aPD-L1 armored anti-CD22 CAR T cells BIOLOGICAL

Autologous aPD-L1 armored CD22-targeting CAR T cells

CD22（aPD-L1）CAR-T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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:
• A) 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.

You may not qualify if:

• Prior therapy with PD-L1 inhibitors
• Prior therapy as follow:
• A) major surgery within 28 days prior to the first study drug treatment (biopsy required for diagnosis is permitted).
• B) 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 \[chest, pericardium, abdominal cavity\]).
• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Zhiyu Wang

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimeng Qiu

CONTACT

15511635920; qiuzhimeng@senlangbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 21, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2025
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)