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SuspendedNCT04650451Updated Apr 20, 2023

Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

A Phase 1 interventional study of chimeric antigen receptor (CAR) T cell therapy in HER-2 Gene Amplification, HER2-positive Gastric Cancer and HER2-positive Breast Cancer, sponsored by Bellicum Pharmaceuticals. Suspended at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Bellicum Pharmaceuticals · Phase 1, Interventional, and Treatment

Why this study was suspended
Due to a Dose Limiting Toxicity in another sister trial with same technology.
Phase
Phase 1
Study type
Interventional
Enrollment
220
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.

Read the detailed description
  • Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid. The first subject in each dose cohort will receive BPX-603 alone (without rimiducid) in order to assess safety of the CAR-T monotherapy.
  • Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-603 persistence and response to temsirolimus as applicable), and clinical activity at the recommended dose for expansion (RDE) identified in Phase 1 in various HER2+ solid tumors.
  • During Phase 1 or 2, temsirolimus (single IV dose at 25 mg) may be administered following BPX-603 infusion in response to treatment-emergent toxicity in order to activate the iRC9 safety switch.
02

Conditions studied

  • HER-2 Gene Amplification
  • HER2-positive Gastric Cancer
  • HER2-positive Breast Cancer
  • HER-2 Protein Overexpression
  • Solid Tumor, Adult

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Keywords

  • HER2
  • CAR-T
  • breast cancer
  • solid tumors
  • gastric cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented evidence of HER2 amplification/overexpression by local testing.
  • Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
  • Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
  • Measurable disease (at least one target lesion) per RECIST v1.1.
  • Life expectancy > 12 weeks.
  • ECOG 0-1.
  • Adequate organ function.

Exclusion criteria

Exclusion Criteria:

  • Symptomatic, untreated, or actively progressing central nervous system metastases.
  • Prior CAR T cell or other genetically-modified T cell therapy.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
  • Severe intercurrent infection.
  • Pregnant or breastfeeding.
  • Known HIV positivity.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    HER2-targeted dual-switch CAR-T cells

    Subjects will receive one dose of BPX-603 on Day 1, followed by rimiducid IV infusion weekly (as tolerated) starting on Day 8 and continued until treatment discontinuation criteria are met.

    Biological: chimeric antigen receptor (CAR) T cell therapy

Interventions

  • Biologicalchimeric antigen receptor (CAR) T cell therapy

    HER2-targeted dual-switch CAR-T cells

    Also known as: CAR-T, BPX-603, autologous CAR-T

05

What researchers measure

Primary outcomes

  1. Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603

    Dose limiting toxicities are defined as BPX-603-related adverse events.

    Time frame: 35 days from time of BPX-603 infusion

  2. Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)

    Identify the optimal dose of BPX-603 for Phase 2.

    Time frame: through Phase 1 completion, up to 2 years

Secondary outcomes

  1. Persistence of HER2-CAR T cells (cell counts)

    The persistence over time of BPX-603 CAR T cells in the peripheral blood as determined by flow cytometry (% CAR+ cells).

    Time frame: measured over time from baseline through study completion, up to 5 years

  2. Expansion of HER2-CAR T cells (vector copy number)

    The expansion over time of BPX-603 CAR T cells in the peripheral blood as determined by qPCR (copies/ug gDNA).

    Time frame: measured over time from baseline through study completion, up to 5 years

  3. Antitumor activity of BPX-603

    Overall response rate

    Time frame: through study completion, up to 5 years

06

Study locations

7 sites
  • City of Hope National Medical Center
    Duarte, California 91010, United States
  • University of California San Diego (UCSD)
    La Jolla, California 92093, United States
  • Winship Cancer Institute at Emory University
    Atlanta, Georgia 322972, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • John Theurer Cancer Center, Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
07

Registry details

Key details

Study ID
NCT04650451
Lead sponsor
Bellicum Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 2, 2020
Start date
Dec 7, 2020
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 2, 2027 (estimated)
Last update
Apr 20, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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