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Clinical Trials/NCT04156243
NCT04156243UnknownEarly Phase 1

Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies

iCell Gene Therapeutics2 sites in 1 country20 target enrollmentStarted: February 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Early Phase 1
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

Detailed Description

CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis based on the World Health Organization (WHO) 2008
  • •Patients have exhausted standard therapeutic options
  • •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  • •Female must be not pregnant during the study

Exclusion Criteria

  • •Prior solid organ transplantation
  • •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  • •Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Outcomes

Primary Outcomes

Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame: 2 years

Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame: 28 days

Type of dose-limiting toxicity (DLT)

Time Frame: 28 days

Secondary Outcomes

  • Overall Response Rate (ORR)(1 year)
  • Progression-free survival (PFS)(1 year)
  • Overall survival(1 year)

Investigators

Sponsor
iCell Gene Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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