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UNKNOWNEARLY_PHASE1

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

Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT03692663•Allife Medical Science and Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To enter the trial, subjects had to meet all of the following eligibility criteria:
•1. diagnosed metastatic castration-resistant prostate cancer (mCRPC);
•2. Castration level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L);
•3. Positive expression of PSMA;
•4. 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);
•5. Expected survival time ≥6 months;
•6. Toxicity of any previous treatment had recovered to ≤ grade 1 at the time of enrollment (except hair loss and hearing loss);
•7. ECOG score of patients 0-1;
•8. Patients voluntarily participated and signed the informed consent, and followed the trial treatment plan and visit plan.

Exclusion Criteria

•Subjects who meet one of the following conditions will not be enrolled in the trial:
•1. 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.;
•2. Previous treatment with any PSMA-targeted therapy;
•3. radiotherapy was administered within 4 weeks prior to the start of study treatment;
•4. Patients with a history of biological macromolecule drug allergy;
•5. 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.)
•6. 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;
•7. A history of severe central nervous system disorders, such as stroke or epilepsy;
•8. 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;
+6 more criteria

Locations (1)

Tianjin pepole's hosptial

Tianjin, China

Key Dates

Start Date

December 1, 2018

Primary Completion Date

June 1, 2023

Completion Date

June 1, 2024

Last Updated

August 1, 2022

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

TABP EIC

DRUG

Cyclophosphamide

BIOLOGICAL

fludarabine

BIOLOGICAL

Contacts

Huaqing Wang, Doctor

CONTACT

18622221223 huaqingw@163.com

Jian Li, Doctor

CONTACT

13032231038 lijian_2016tj@163.com

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer