Clinical trial NCT04502446: A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: T Cell Lymphoma
Keywords: CAR T
Allogeneic
Lymphoma
Lead sponsor: CRISPR Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part A (dose escalation)
timeFrame: From CTX130 infusion up to 28 days post-infusion
measure: Part B (cohort expansion)
timeFrame: From CTX130 infusion up to 60 months post-infusion]
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
measure: Overall Survival
timeFrame: From date of CTX130 until date of death due to any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Research Site 2
state: California
city: Stanford
country: United States
facility: Research Site 5
state: California
city: New Haven
country: United States
facility: Research Site 10
state: Connecticut
city: Miami
country: United States
facility: Research Site 4
state: Florida
city: Bronx
country: United States
facility: Research Site 8
state: New York
city: New York
country: United States
facility: Research Site 9
state: New York
city: Houston
country: United States
facility: Research Site 1
state: Texas
city: Salt Lake City
country: United States
facility: Research Site 6
state: Utah
city: Sydney
country: Australia
facility: Research Site 3
state: New South Wales
city: Toronto
country: Canada
facility: Research Site 7
state: Ontario
Study officials:
affiliation: CRISPR Therapeutics
name: Alissa Keegan, PhD
role: STUDY_DIRECTOR
References: