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

NCT04502446 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CRSP-ONC-004
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 10

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.

Conditions

T Cell Lymphoma

Keywords

CAR T; Allogeneic; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Part A (dose escalation)

  Incidence of adverse events

  From CTX130 infusion up to 28 days post-infusion

• Part B (cohort expansion)

  Objective response rate

  From CTX130 infusion up to 60 months post-infusion]

Secondary Outcomes (2)

• 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

Study Arms (1)

CTX130

EXPERIMENTAL

Administered by IV infusion following lymphodepleting chemotherapy.

Biological: CTX130

Interventions

CTX130 BIOLOGICAL

CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

CTX130

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate renal, liver, cardiac, and pulmonary organ function.
• 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.

You may not qualify if:

• Prior allogeneic stem cell transplant (SCT).
• Prior treatment with any anti-CD70 targeting agents.
• History of certain central nervous system (CNS), cardiac or pulmonary conditions.
• Active HIV, hepatitis B virus or hepatitis C virus infection.
• 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.
• Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
• Prior solid organ transplantation.
• Pregnant or breastfeeding females.

Sponsors & Collaborators

• CRISPR Therapeutics AG: lead

Study Sites (10)

Research Site 2

Duarte, California, 91010, United States

Location

Research Site 5

Stanford, California, 94305, United States

Location

Research Site 10

New Haven, Connecticut, 06520, United States

Location

Research Site 4

Miami, Florida, 33124, United States

Location

Research Site 9

New York, New York, 10065, United States

Location

Research Site 8

The Bronx, New York, 10467, United States

Location

Research Site 1

Houston, Texas, 77030, United States

Location

Research Site 6

Salt Lake City, Utah, 84112, United States

Location

Research Site 3

Sydney, New South Wales, 2050, Australia

Location

Research Site 7

Toronto, Ontario, M5G 2C1, Canada

Location

Related Publications (2)

• Iyer SP, Sica RA, Ho PJ, Prica A, Zain J, Foss FM, Hu B, Beitinjaneh A, Weng WK, Kim YH, Khodadoust MS, Huen AO, Williams LM, Ma A, Huang E, Ganpule A, Nagar SD, Sripakdeevong P, Cullingford EL, Karnik S, Dequeant ML, Patel JN, He XS, Li Z, He QA, Mendonez JH, Keegan A, Horwitz SM. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. Lancet Oncol. 2025 Jan;26(1):110-122. doi: 10.1016/S1470-2045(24)00508-4. Epub 2024 Nov 29.

  PMID: 39617017 DERIVED

• Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.

  PMID: 37093350 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alissa Keegan, PhD

  CRISPR Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: July 31, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (1); US (8)