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

T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04502446
• Other study ID #: CRSP-ONC-004
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 31, 2020
• Est. completion date: May 2027

Study information

• Verified date: April 2023
• Source: CRISPR Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study may enroll approximately 45 subjects in total.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• T Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
Australia	Research Site 3	Sydney	New South Wales
Canada	Research Site 7	Toronto	Ontario
United States	Research Site 8	Bronx	New York
United States	Research Site 2	Duarte	California
United States	Research Site 1	Houston	Texas
United States	Research Site 4	Miami	Florida
United States	Research Site 10	New Haven	Connecticut
United States	Research Site 9	New York	New York
United States	Research Site 6	Salt Lake City	Utah
United States	Research Site 5	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
CRISPR Therapeutics AG

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A (dose escalation)	Incidence of adverse events	From CTX130 infusion up to 28 days post-infusion
Primary	Part B (cohort expansion)	Objective response rate	From CTX130 infusion up to 60 months post-infusion]
Secondary	Progression Free Survival		From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Secondary	Overall Survival		From date of CTX130 until date of death due to any cause, assessed up to 60 months