RECRUITING

PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer

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Conditions

Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving PSCA-targeting CAR T-cells, with or without radiation, may kill more tumor cells in men with castration-resistant prostate cancer.

Official Title

A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer

Quick Facts

Study Start:2024-07-19
Study Completion:2026-11-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05805371

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative (brown)
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with lymphodepletion and CAR T cell infusion only after the translated main consent form is signed
  4. * Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  5. * If unavailable, exceptions may be granted with study principal investigator (PI) approval
  6. * Age: \>= 18 years
  7. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (KPS) \>= 70%
  8. * Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist therapy)
  9. * Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)
  10. * Fresh or archival biopsy samples may be tested for PSCA expression during screening for eligibility purposes. The results from soft tissue biopsies will be used to confirm eligibility for participants who have a soft-tissue lesion biopsy obtained, but bone biopsy staining results will not impact eligibility since immunohistochemistry (IHC) staining for PSCA has not been optimized in bone specimens. Subjects who undergo bone biopsy on study will be qualified based on the archival tissue result
  11. * Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide):
  12. * Rising prostate specific antigen (PSA) documented on 2 occasions at least 7 days apart, with absolute increase \> 2 ng/dL despite testosterone \< 50 OR
  13. * Radiographic evidence of new metastatic foci on CT or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)
  14. * For treatment plan 2, subjects must have at least one and up to 3 metastatic lesions which have not previously been radiated and which is safe for treatment with radiation 16 gray (Gy) in 2 fractions
  15. * Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy
  16. * If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis
  17. * Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was completed \> 14 days prior to leukapheresis
  18. * No known contraindications to leukapheresis, steroids or tocilizumab
  19. * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 42 days prior to enrollment)
  20. * NOTE: Growth factor is not permitted within 14 days of ANC assessment
  21. * Platelets \>= 100,000/mm\^3 (within 42 days prior to enrollment) NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
  22. * Total serum bilirubin =\< 2.0 mg/dL (within 42 days prior to enrollment)
  23. * Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN
  24. * Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 42 days prior to enrollment)
  25. * Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 42 days prior to enrollment)
  26. * Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 42 days prior to enrollment)
  27. * Corrected QT interval (QTc) =\< 480 ms
  28. * Note: to be performed within 28 days prior to day 1 of protocol therapy
  29. * Cardiac function (12 lead- electrocardiogram \[ECG\]) without acute abnormalities requiring investigation or intervention (within 42 days prior to enrollment)
  30. * Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])
  31. * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR
  32. * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
  33. * Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  34. * Meets other institutional and federal requirements for infectious disease titer requirements
  35. * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  36. * Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
  37. * Childbearing potential defined as not being surgically sterilized
  1. * Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\< 7.5 mg /day, or hydrocortisone =\< 20 mg /day) is allowed
  2. * Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
  3. * Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder
  4. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  5. * Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
  6. * History of stroke or intracranial hemorrhage within 6 months prior to screening
  7. * History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years
  8. * Clinically significant uncontrolled illness
  9. * Active infection requiring antibiotics
  10. * Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  11. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  12. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Tanya B Dorff
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Tanya B Dorff, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

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 Registration Dates

Study Start Date2024-07-19
Study Completion Date2026-11-11

Study Record Updates

Study Start Date2024-07-19
Study Completion Date2026-11-11

Terms related to this study

Additional Relevant MeSH Terms

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8