A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies

CRISPR Therapeutics AG10 sites in 3 countries49 target enrollmentJuly 31, 2020

ConditionsT Cell Lymphoma

InterventionsCTX130

DrugsCTX130

Overview

Phase: Phase 1
Intervention: CTX130
Conditions: T Cell Lymphoma
Sponsor: CRISPR Therapeutics AG
Enrollment: 49
Locations: 10
Primary Endpoint: Part B (cohort expansion)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

Detailed Description

The study may enroll approximately 45 subjects in total.

Registry

clinicaltrials.gov

Start Date

July 31, 2020

End Date

August 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

CRISPR Therapeutics AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

CTX130

Administered by IV infusion following lymphodepleting chemotherapy.

Intervention: CTX130

Outcomes

Primary Outcomes

Part B (cohort expansion)

Time Frame: From CTX130 infusion up to 60 months post-infusion]

Objective response rate

Part A (dose escalation)

Time Frame: From CTX130 infusion up to 28 days post-infusion

Incidence of adverse events

Secondary Outcomes

Progression Free Survival(From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months)
Overall Survival(From date of CTX130 until date of death due to any cause, assessed up to 60 months)