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

March 20, 2024 updated by: CRISPR Therapeutics AG

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study may enroll approximately 45 subjects in total.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Research Site 3
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C1
        • Research Site 7
  • United States
    • California
      • Duarte, California, United States, 91010
        • Research Site 2
      • Stanford, California, United States, 94305
        • Research Site 5
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Research Site 10
    • Florida
      • Miami, Florida, United States, 33124
        • Research Site 4
    • New York
      • Bronx, New York, United States, 10467
        • Research Site 8
      • New York, New York, United States, 10065
        • Research Site 9
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site 1
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (abbreviated):

  1. Age ≥18 years.
  2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. Adequate renal, liver, cardiac, and pulmonary organ function.
  5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Exclusion Criteria (abbreviated):

  1. Prior allogeneic stem cell transplant (SCT).
  2. Prior treatment with any anti-CD70 targeting agents.
  3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
  4. Active HIV, hepatitis B virus or hepatitis C virus infection.
  5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
  6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  7. Prior solid organ transplantation.
  8. Pregnant or breastfeeding females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTX130
Administered by IV infusion following lymphodepleting chemotherapy.
Biological: CTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Time Frame: From date of CTX130 until date of death due to any cause, assessed up to 60 months
From date of CTX130 until date of death due to any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CRISPR Therapeutics AG

Investigators

  • Study Director: Alissa Keegan, PhD, CRISPR Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRSP-ONC-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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