Lymphodepletion followed by TC-510 for Cancer of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Cancer Institute, Bethesda, MD
Cancer of Pancreas+18 More
Fludarabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

Eligible Conditions

  • Cancer of Pancreas
  • Ovary Cancer
  • Mesothelioma, Malignant
  • Ovarian Serous Adenocarcinoma
  • Adenocarcinomas of the Pancreas
  • Adenocarcinoma of the Ovaries
  • Colorectal Cancer
  • Mesothelioma
  • Pleural Mesotheliomas
  • Mesothelioma; Peritoneum
  • Ovarian Cancer
  • Malignant Neoplasm of Pancreas
  • Colorectal Carcinoma (CRC)
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Pancreas

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 2 years post-treatment

Day 28
Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Year 2
Phase 2 - Disease Control Rate (DCR)
Phase 2 - Overall Response Rate (ORR)

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer of Pancreas

Trial Design

1 Treatment Group

Lymphodepletion followed by TC-510
1 of 1
Experimental Treatment

115 Total Participants · 1 Treatment Group

Primary Treatment: Lymphodepletion followed by TC-510 · No Placebo Group · Phase 1 & 2

Lymphodepletion followed by TC-510Experimental Group · 3 Interventions: Fludarabine, TC-510, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 2
~1240
Cyclophosphamide
1995
Completed Phase 3
~4020

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years post-treatment
Closest Location: National Cancer Institute · Bethesda, MD
2005First Recorded Clinical Trial
0 TrialsResearching Cancer of Pancreas
120 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have adequate organ function as indicated by the laboratory values in the clinical protocol.
You are fit for leukapheresis and have adequate venous access for the cell collection.
You have a minimum age of 18 years.
Patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol.

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.