Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer

April 26, 2022 updated by: The Affiliated Hospital of Xuzhou Medical University
This is an experimental study to evaluate the safety and effectiveness of PSMA-targeted CAR-T cells in the treatment of castration-resistant prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We designed a clinical study and divided the trial into two phases.

Phase 1 (climbing test): 9 patients were randomly divided into 3 groups (n=3). 9 patients were treated with cyclophosphamide at the dose of 60mg/kg/d 8-7 days before CAR-T cell infusion, and fludalabine at the dose of 25mg/m^2/d 6-2 days before CAR-T cell infusion. On Day 0, CAR T cells were injected into patients in group 1, 2 and 3 at the dose of 1*10^8/ person, 1*10^9/ person and 1*10^10/ person, respectively. The infusion time exceeded 15-30min. On day 0-14, IL-2 (75000IU/kg) was injected subcutaneously once a day. From day 15-28, IL-2 (75000IU/kg) was subcutaneously injected into the patients three times a week. The purpose of this study is to assess subjects' MTD (maximum tolerated dose) against CAR T cells.

Phase 2: After determining the appropriate therapeutic dose for patients with prostate cancer, the remaining 11 patients received the same pre-treatment of chemotherapy. Then, the appropriate therapeutic dose of CAR T cells according to the results of phase 1 was infused on Day 0. On day 0-14,IL-2 (75000IU/kg) was given subcutaneously once a day. On day 15-28, IL-2 (75000IU/kg) was given subcutaneously three times a week.

Subjects will collect peripheral blood every four weeks, detect PSA and other related indicators to evaluate the curative effect, safety and survival rate of CAR-T cell transplantation. After 6 months of close follow-up, the subjects will have a quarterly medical history assessment, physical examination and blood test, bone metastasis assessment by bone ECT, prostate and pelvic cavity assessment by prostate MRI, and general information by PET CT if necessary for two years. After this assessment, the subjects will enter an annual telephone follow-up and questionnaire survey for up to five years to assess the long-term health problems of treatment, such as recurrence of malignant tumors.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male patients aged from 18 to 75 years old;
  2. The patients' ECOG score ≤ 2;

  3. Prostate cancer patients in castration resistance stage (with or without distant metastasis):

    1. Previous new endocrine therapy is ineffective;
    2. Past treatment with too much citabine or cabatase is ineffective.
  4. Have measurable or evaluable lesions;

  5. The patients' main tissues and organs function well:

    1. Liver function: ALT/AST < 3 times the upper limit of normal value (ULN);
    2. renal function: creatinine < 220 μ mol/L;
    3. Lung function: indoor oxygen saturation ≥ 95%;
    4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40%
  6. Patients or their legal guardians voluntarily participate and sign the informed consent form.

Exclusion Criteria:

  1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.);
  2. Feasibility evaluation screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification under the co-stimulation of CD3/CD28 is insufficient (< 5 times);
  3. The vital signs are abnormal and those who cannot cooperate with the inspectors;
  4. Those with mental illness or mental illness who can't cooperate with treatment and curative effect evaluation;
  5. Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2;
  6. Subjects with systemic infection or local severe infection who need anti-infection treatment;
  7. Complicated dysfunction of heart, lung, brain, liver, kidney and other important organs;
  8. Patients with other tumors;
  9. Doctors think that there are other reasons that can't be included in the treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T cell immunotherapy
The registered patients will receive CAR-T cell immunotherapy for the new specific chimeric antigen receptor of PSMA antigen by infusion.
Biological: CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at PSMA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation:Incidence and Severity of Adverse Events
Time Frame: First 1 month after CAR-T cells infusion
To evaluate the incidence and severity of possible adverse events within one month after targeted PSMA CAR-T infusion, including cytokine release syndrome and on-target toxicity.
First 1 month after CAR-T cells infusion
Effectiveness Evaluation
Time Frame: 3 months after CAR-T cells infusion
In order to observe the efficacy of CAR-T cells after infusion, total remission rate (ORR), complete remission (CR), partial remission (PR), disease stability (SD) or progression (PD) will be used for evaluation.
3 months after CAR-T cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 24 months after CAR-T cells infusion
Progression-free survival (PFS) time
24 months after CAR-T cells infusion
Overall Survival (OS)
Time Frame: 24 months after CAR-T cells infusion
Overall survival (OS) time
24 months after CAR-T cells infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborators

Xuzhou Medical University

Investigators

  • Study Director: Junnian Zheng, M.D/Ph.D, The Affiliated Hospital of Xuzhou Medical University
  • Principal Investigator: Hailong Li, M.D/Ph.D, The Affiliated Hospital of Xuzhou Medical University
  • Principal Investigator: Qing Zhang, Ph.D, Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

November 30, 2025

Study Completion (Anticipated)

November 30, 2026

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2021-KL172-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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