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Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

NCT04282044 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-08

No results posted yet for this study

Summary

This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma.

The study will start with monotherapy dose escalation followed by combination cohorts.

Conditions

Interventions

BIOLOGICAL

CRX100 suspension for infusion

A fixed dose of CIK cells combined with the specified dose of CDSR.

COMBINATION_PRODUCT

Fludarabine

25mg/m IV (five doses given from Day -7 until Day -3)

COMBINATION_PRODUCT

Cyclophosphamide

60mg/kg intravenous (IV) (two doses given on Day -7 and -6)

Sponsors & Collaborators

  • BioEclipse Therapeutics

    lead INDUSTRY

Principal Investigators

  • Oliver Dorigo, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2025-08-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282044 on ClinicalTrials.gov