Clinical trial NCT05795595: A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
Official title: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Cervical Carcinoma
Esophageal Carcinoma
Pancreatic Adenocarcinoma
Malignant Pleural Mesothelioma
Keywords: CAR-T
Allogeneic
Carcinoma
Lead sponsor: CRISPR Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 250
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 an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

Detailed description: An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility criteria: Key Inclusion Criteria:

1. Age ≥18 years.
2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
3. Eastern Cooperative Oncology Group performance status 0 or 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 CTX131 infusion.

Key Exclusion Criteria:

1. Prior treatment with anti-CD70 targeting agents
2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
3. Presence of uncontrolled bacterial, viral, or fungal infection.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
6. Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Phase 1 (Dose Escalation): Incidence of adverse events
timeFrame: From CTX131 infusion up to 28 days post-infusion
measure: Phase 2 (Cohort Expansion): Objective response rate (ORR)
timeFrame: From CTX131 infusion up to 60 months post-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Research Site 3
state: California
city: Chicago
country: United States
facility: Research Site 7
state: Illinois
city: Boston
country: United States
facility: Research Site 6
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site 2
state: Missouri
city: Durham
country: United States
facility: Research Site 4
state: North Carolina
city: Nashville
country: United States
facility: Research Site 1
state: Tennessee
city: Houston
country: United States
facility: Research Site 5
state: Texas
Study officials:
affiliation: CRISPR Therapeutics
name: Alissa Keegan, MD, PhD
role: STUDY_DIRECTOR
References: