Study of Anti-PSMA CAR NK Cell (TABP EIC) in Metastatic Castration-Resistant Prostate Cancer

NCT03692663 | Unknown Early Phase 1 DMC

• 1 other identifier: TABP EIC-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of TABP EIC in patients with Metastatic castration-resistant prostate cancer.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment related adverse events as assessed by CTCAE v5.0

  Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

  Baseline to 1 year post infusion

Secondary Outcomes (5)

• The pharmacokinetic analysis of TABP EIC

  D0, D1, D3, D7, D8, D10, D14, D15, D17, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion

• The pharmacodynamics analysis of TABP EIC

  Baseline to infusion date, D28±1, D60±2, D120±2, D180±7, D270±7, 和 D365±7

• The proportion of patients with a decrease in PSA levels from baseline.

  Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion

• Progression-free survival (PFS) after TABPEIC infusion

  Baseline to 1 year post infusion

• Time to clinical progression

  Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion

Study Arms (1)

TABP EIC treatment group

EXPERIMENTAL

Drug: TABP EIC Experimental Interventional Therapy

Drug: TABP EIC; Biological: Cyclophosphamide; Biological: fludarabine

Interventions

TABP EIC DRUG

A single dose of 0.5, 10, and 30 million TABP EIC will be iv administered at D0, D7, and D14.

TABP EIC treatment group

Cyclophosphamide BIOLOGICAL

Cyclophosphamide will be iv administered with 250 mg/m\^2 at D-3, D-2, and D-1 before TABP EIC infusion.

TABP EIC treatment group

fludarabine BIOLOGICAL

Fludarabine will be iv administered with 25 mg/m\^2 at D-3, D-2, and D-1 before TABP EIC infusion.

TABP EIC treatment group

Eligibility Criteria

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

You may qualify if:

• To enter the trial, subjects had to meet all of the following eligibility criteria:
• diagnosed metastatic castration-resistant prostate cancer (mCRPC);
• Castration level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L);
• Positive expression of PSMA;
• According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:
• A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA \> 2 ng/mL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter \> 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);
• Expected survival time ≥6 months;
• Toxicity of any previous treatment had recovered to ≤ grade 1 at the time of enrollment (except hair loss and hearing loss);
• ECOG score of patients 0-1;
• Patients voluntarily participated and signed the informed consent, and followed the trial treatment plan and visit plan.

You may not qualify if:

• Subjects who meet one of the following conditions will not be enrolled in the trial:
• Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
• Previous treatment with any PSMA-targeted therapy;
• radiotherapy was administered within 4 weeks prior to the start of study treatment;
• Patients with a history of biological macromolecule drug allergy;
• Abnormal function of major organs:
• A. Neutrophil count (ANC) \< 1.5×109/L; Platelet count (Plt) \< 100×109/L; Hemoglobin (Hb) \< 9 g/dL; B. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN (≥5×ULN for liver metastases); C. Renal function: serum creatinine (Cr) ≥1.5×ULN; D. Prothrombin time (PT) \> 15 s, activated partial thrombin time (APTT) was prolonged or shortened by more than 10 s (normal reference value 23 s-37 s), or international normalized ratio (INR) \> 1.7; E. Pulmonary function: Severe respiratory diseases (active pulmonary tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
• Patients required systemic long-term steroid use or had received systemic steroids (dose equivalent to prednisone \>10 mg/ day, except for patients using inhaled hormones) or other immunosuppressive agents 30 days before enrollment;
• A history of severe central nervous system disorders, such as stroke or epilepsy;
• active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;
• have had other malignancies other than prostate cancer (other than basal or squamous cell skin cancer) in the past 5 years that are currently clinically significant and require intervention;
• Clinically significant heart disease (New York Heart Association class III/IV, left ventricular ejection fraction \< 60%);
• Any active (viral, bacterial, fungal) infection currently being treated or any infection requiring intravenous antibiotics for 7 or more days or intervals during the past 6 weeks or any active infection requiring oral antibiotics during the past 1 week;
• untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA≥1000 copies /mL, or active hepatitis C patients;
• Patients who have participated in other clinical trials and used study drugs within 3 months;

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead
• Tianjin People's Hospital: collaborator

Study Sites (1)

Tianjin pepole's hosptial

Tianjin, 300000, China

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; fludarabine

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Huaqing Wang, Doctor

  Oncology of Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, Tianjin

  PRINCIPAL INVESTIGATOR

• Jian Li, Doctor

  Urinary surgeryof Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, Tianjin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Wang, Doctor

CONTACT

18622221223; huaqingw@163.com

Jian Li, Doctor

CONTACT

13032231038; lijian_2016tj@163.com

Study Design

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

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)