CDX-1140 + TCR-T + Pembro for Malignant Epithelial Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Providence Portland Medical Center, Portland, OR
Malignant Epithelial Neoplasms+2 More
TCR-transduced T cells - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Simon's Two-Stage expansion design, 80% power and 5% one-sided alpha: stage-one futility assessment at n = 10; stage-two assessment at n = 22, (accrual up to 24 to allow for potential study drop-out).

Eligible Conditions

  • Malignant Epithelial Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 2 years

2 years
Clinical benefit rate
Duration of response
Incidence of adverse events
Objective response rate
Overall survival
Severity of adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CDX-1140 + TCR-T + Pembro
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: CDX-1140 + TCR-T + Pembro · No Placebo Group · Phase 1

CDX-1140 + TCR-T + PembroExperimental Group · 3 Interventions: TCR-transduced T cells, CDX-1140, Pembrolizumab · Intervention Types: Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Providence Portland Medical Center · Portland, OR
Photo of Portland  1Photo of Portland  2Photo of Portland  3
2013First Recorded Clinical Trial
2 TrialsResearching Malignant Epithelial Neoplasms
173 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a platelet count of at least 100,000 cells/mm3.
Creatinine must be ≤ 2.0 mg/dL.
You have metastatic or locoregionally advanced epithelial cancers, that are considered incurable.
You have an ECOG performance status of 0, 1 or 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.