A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

Phase 1

Terminated

• Conditions: T Cell Lymphoma
• Interventions: Biological: CTX130

• Registration Number: NCT04502446
• Lead Sponsor: CRISPR Therapeutics AG

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2020-07-31
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CTX130	CTX130	Administered by IV infusion following lymphodepleting chemotherapy.

Primary Outcome Measures

Name	Time	Method
Part B (cohort expansion)	From CTX130 infusion up to 60 months post-infusion]	Objective response rate
Part A (dose escalation)	From CTX130 infusion up to 28 days post-infusion	Incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Research Site 9; 🇺🇸 New York, New York, United States

Research Site 1; 🇺🇸 Houston, Texas, United States

Research Site 7; 🇨🇦 Toronto, Ontario, Canada

Research Site 3; 🇦🇺 Sydney, New South Wales, Australia

Research Site 2; 🇺🇸 Duarte, California, United States

Research Site 4; 🇺🇸 Miami, Florida, United States

Research Site 10; 🇺🇸 New Haven, Connecticut, United States

Research Site 8; 🇺🇸 Bronx, New York, United States

Research Site 6; 🇺🇸 Salt Lake City, Utah, United States

Research Site 5; 🇺🇸 Stanford, California, United States