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

Last updated: January 7, 2025
Sponsor: CRISPR Therapeutics AG
Overall Status: Terminated

Phase

1

Condition

N/A

Treatment

CTX130

Clinical Study ID

NCT04502446
CRSP-ONC-004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: CTX130
Phase: 1
Study Start date:
July 31, 2020
Estimated Completion Date:
August 30, 2024

Study Description

The study may enroll approximately 45 subjects in total.

Connect with a study center

  • Research Site 3

    Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Research Site 7

    Toronto, Ontario M5G 2C1
    Canada

    Site Not Available

  • Research Site 2

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site 5

    Stanford, California 94305
    United States

    Site Not Available

  • Research Site 10

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Research Site 4

    Miami, Florida 33124
    United States

    Site Not Available

  • Research Site 8

    Bronx, New York 10467
    United States

    Site Not Available

  • Research Site 9

    New York, New York 10065
    United States

    Site Not Available

  • Research Site 1

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site 6

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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