chimeric antigen receptor (CAR) T cell therapy for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Bellicum Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through phase 1 completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using modified immune cells to target specific cancer markers in patients with advanced tumors. The treatment is managed by a drug to ensure safety and effectiveness.

Eligible Conditions

Breast Cancer
Gastric Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through phase 1 completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through phase 1 completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through phase 1 completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Antitumor activity of BPX-603

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

Persistence of HER2-CAR T cells (cell counts)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HER2-targeted dual-switch CAR-T cellsExperimental Treatment1 Intervention

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.

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