A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

NCT06215950 | Recruiting Phase 1

• 1 other identifier: PBC061
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.

Conditions

Ovarian Cancer; Cervix Cancer; Metastatic Cancer; Advanced Cancer; Gynecologic Cancer

Keywords

CAR-T; CD70

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse events after CD70 CAR-T cells infusion [Safety and Tolerability]

  Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  28 days

• Obtain the maximum tolerated dose of CD70 CAR-T cells[Safety and Tolerability]

  Dose-limiting toxicity after cell infusion

  28 days

Secondary Outcomes (9)

• Disease control rate of CAR-T cell preparations in CD70 positive advanced malignancies [Effectiveness]

  3 months

• Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

  3 months

• Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

  2 years

• Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

  2 years

• Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

  2 years

Other Outcomes (5)

• The correlation between CD70 positive rate and safety

  2 years

• Correlation between CD70 positive rate and efficacy

  2 years

• Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

  2 years

Study Arms (2)

Intravenous of CD70-targeted CAR-T

EXPERIMENTAL

Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg

Biological: CD70 CAR-T cells

intraperitoneal injection of CD70-targeted CAR-T

EXPERIMENTAL

Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg

Biological: CD70 CAR-T cells

Interventions

CD70 CAR-T cells BIOLOGICAL

After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically

Intravenous of CD70-targeted CAR-T

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old;
• Advanced/metastatic gynecological tumor confirmed by histopathology or cytology (paraffin sections or fresh biopsy tumor tissue specimens) (CD70 positive tumor expression (CD70 positive tumor confirmed by histology or pathology (IHC 3+));
• Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and currently no effective treatment;
• According to the RECIST version 1.1 standard, there is at least one measurable diameter and evaluable target lesion. Measurable lesions are defined as: extranodal lesions with CT scan diameter ≥10mm, lymph node lesions with CT scan diameter ≥15mm, scan layer thickness ≤ 5mm, and have not received local treatment;
• ECOG 0 \~ 2 points ;
• Expected survival time is more than 12 weeks;
• No serious mental disorders;
• The functions of important organs are basically normal:
• Hematopoietic function: neutral granules \>1.0×109/L, platelet \>75×109/L, hemoglobin \>80g/L;
• Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
• Renal function: serum creatinine ≤2.0×ULN;
• Liver function: ALT and AST ≤2.0×ULN (patients with liver tumor infiltration can be relaxed to ≤3.0×ULN);
• Total bilirubin ≤2.0×ULN (Gilbert syndrome or liver tumor infiltration can be relaxed to ≤3.0×ULN);
• Blood oxygen saturation in non-oxygen state\>92%.
• Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;

You may not qualify if:

• Received anti-CD70 drug therapy before screening;
• Active/symptomatic central nervous system metastasis or meningeal metastasis at the time of screening; Treated subjects with brain metastases can only be enrolled if no radiographically demonstrated progression is demonstrated ≥4 weeks after the end of treatment.
• Received any of the following treatments prior to screening:
• Participated in other interventional clinical studies before screening, including: the time of last use of unmarketed new drugs less than 3 months from cell transfusion, or the time of last use of marketed drugs less than 5 half-lives from cell transfusion;
• Received anti-tumor therapy such as chemotherapy or targeted therapy within 2 weeks of preapheresis or at least 5 half-lives (whichever is shorter); Received systemic radiation within 4 weeks and local radiation within 2 weeks; Or received radioactive drugs (strontium, samarium) within 8 weeks prior to treatment.
• Systemic corticosteroid therapy with doses greater than 10mg/ day of prednisone (or equivalent doses of other corticosteroids) within 2 weeks of preapheresis (in the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical replacement with doses greater than 10mg/ day of prednisone efficacy dose are permitted);
• Received live attenuated vaccine within 4 weeks prior to screening;
• There is an active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
• Had malignancies other than the target tumor within 3 years prior to screening, except for malignancies that had received radical treatment and had no known active disease for ≥3 years prior to enrollment; Or adequately treated non-melanoma skin cancer with no evidence of disease;
• Have any of the following heart conditions:
• New York Heart Association (NYHA) Stage III or IV congestive heart failure;
• Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;
• A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy.
• Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guantai Ni, M.D

  First Affiliated Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guantai Ni, M.D

CONTACT

13705535528; niguantai@yjsyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)