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Trial record 1 of 1 for:    BPX-601
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Use of Ligand-Inducible Autologous T Cells Engineered to Target PSCA on Tumor Cells in Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02744287
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bellicum Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety and activity of BPX-601 in participants with previously treated advanced solid tumors (pancreatic, stomach, or prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Gastric Adenocarcinoma Prostate Adenocarcinoma Biological: BPX-601 Drug: Rimiducid Phase 1 Phase 2

Detailed Description:

The goal of this study is to characterize the feasibility, safety, and clinical activity of PSCA-specific CAR-T cells, BPX-601, administered with rimiducid to subjects with previously treated, PSCA-positive advanced solid tumors (pancreatic, stomach, or prostate). BPX-601 CAR-T cells are genetically engineered to express a rimiducid-inducible signaling domain which functions as a molecular switch to enhance activation and proliferation.

The study will be comprised of multiple parts:

  • Part 1 (Phase 1): Cell dose escalation to identify the maximum dose of BPX-601 T cells (escalating doses from 1.25 x 10E6 cells/kg up to 5.0 x 10E6 cells/kg to be explored) administered with rimiducid (fixed single-dose at 0.4 mg/kg)
  • Parts 2 and 3 (Phase 2): Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 T cell persistence), and clinical activity at the recommended dose identified in Part 1 in various PSCA-expressing solid tumors

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Feasibility, Safety, and Activity Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Previously Treated Advanced Solid Tumors
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Part 1 Dose Escalation
Participants with advanced pancreas, stomach, or prostate cancer will receive an intravenous infusion of BPX-601 followed by an intravenous infusion of rimiducid. Dose escalation of BPX-601 will continue until the recommended cell dose level is reached.
Biological: BPX-601
Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain

Drug: Rimiducid
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved persistence
Other Name: AP1903

Experimental: Arm 2: Parts 2 and 3 Dose Expansion
Participants with advanced pancreas, stomach, or prostate cancer will receive an intravenous infusion of BPX-601 at the recommended cell dose level followed by an intravenous infusion of rimiducid.
Biological: BPX-601
Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain

Drug: Rimiducid
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved persistence
Other Name: AP1903




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 35 days after BPX-601 treatment ]
    Incidence of dose limiting toxicity

  2. Treatment emergent adverse events (AEs) and serious AEs (SAEs) [ Time Frame: 180 days after BPX-601 treatment up to 15 years ]
    Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03

  3. Pharmacodynamics (PD) of BPX-601 T cells [ Time Frame: up to 15 years after treatment ]
    Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells

  4. Overall Response Rate (ORR) [ Time Frame: 1 year ]
    Percentage of subjects with objective response determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the Prostate Cancer Working Group 3 (PCWG3) criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants with either:

    1. Metastatic pancreatic cancer with tumor progression after one prior standard chemotherapy; or,
    2. Metastatic gastric or gastroesophageal junction cancer with tumor progression after one prior standard chemotherapy; or,
    3. Hormone-refractory prostate cancer with tumor progression following treatment with a taxane-containing regimen and at least one androgen synthesis inhibitor.
  2. Tumor with positive PSCA expression as determined by central testing.
  3. Participant has a radiographically measurable tumor.
  4. Age ≥18 years
  5. Participant has a life expectancy >12 weeks and is able to carry out daily life activities without difficulty (Eastern Cooperative Oncology Group performance status 0 or 1).
  6. Participant has adequate venous access for apheresis or agree to use of a central line for apheresis collection
  7. Participant does not have significant side effects from previous anticancer treatment.
  8. Participant has adequate organ and blood cell counts.
  9. Sexually active participants must use medically acceptable methods of contraception for at least 1 year after study treatment.

Exclusion Criteria:

  1. Pancreatic cancer with islet cell neoplasms or symptomatic coagulopathy.
  2. Gastric/GEJ with:

    1. Abnormal kidney function
    2. Non-healing wound, peptic ulcer, or bone fracture within 4 weeks of study treatment
    3. History of gastric perforation and/or fistula within 6 months of study treatment
    4. Bowel obstruction, history or presence of other inflammatory enteropathy including Crohn's disease, ulcerative colitis, or chronic diarrhea
    5. Chronic treatment with non-steroidal anti-inflammatory agents or anti-platelet agents
    6. Significant bleeding disorder
    7. Symptomatic coagulopathy
  3. Prostate cancer with unstable bone lesions or symptomatic coagulopathy.
  4. Participant has a history of major surgery or treatment with other cancer therapy within 2-4 weeks before study treatment.
  5. Participant has an untreated brain tumor.
  6. Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics within 2 weeks before study treatment.
  7. History of clinically significant heart problems.
  8. Participant is currently pregnant or breastfeeding.
  9. Participant requires chronic, systemic steroid therapy.
  10. Participant has an active, autoimmune disease that requires immunosuppressive therapy. Exceptions are vitiligo, type I diabetes, certain cases of hypothyroidism and psoriasis, or Hashimoto's thyroiditis on a stable dose of thyroid replacement therapy
  11. Participant is positive for Hepatitis B, Hepatitis C, HIV, syphilis, West Nile virus, or Chagas disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744287


Contacts
Contact: Bellicum Pharmaceuticals Clinical Development medcommsmail011@bellicum.com

Locations
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Principal Investigator    813-745-7238    Donna.Evans2@moffitt.org   
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Principal Investigator    212-342-0248    as5713@cumc.columbia.edu   
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Principal Investigator    214-818-8472      
Sponsors and Collaborators
Bellicum Pharmaceuticals
Investigators
Study Director: Bellicum Pharmaceuticals Senior Director Clinical Development

Responsible Party: Bellicum Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02744287     History of Changes
Other Study ID Numbers: BP-012
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bellicum Pharmaceuticals:
prostate stem cell antigen
BPX-601
AP1903
CAR T
PSCA-CAR
Hormone-refractory prostate cancer
rimiducid
gastric cancer
gastroesophageal junction cancer
pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms