A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies
1 other identifier
interventional
120
2 countries
7
Brief Summary
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Start
First participant enrolled
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
November 14, 2025
November 1, 2025
6.8 years
November 30, 2022
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
From CTX112 infusion up to 60 months post-infusion
Secondary Outcomes (4)
Duration of Response
From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
Duration of Clinical Benefit (DOCB)
From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
Progression Free Survival
From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
Study Arms (1)
CTX112
EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy.
Interventions
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Refractory or relapsed B cell malignancy.
- Eastern Cooperative Oncology Group performance status 0 or 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 CTX112 infusion.
You may not qualify if:
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Active or history of central nervous system (CNS) involvement by malignancy.
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
- Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Kansas
Westwood, Kansas, 66205, United States
Washington University
St Louis, Missouri, 63110, United States
SCRI
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Royal Prince Alfred
Camperdown, New South Wales, 2050, Australia
Alfred Health
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Melanie Allen, M.Sc.
CRISPR Therapeutics
Central Study Contacts
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
November 30, 2022
First Posted
December 9, 2022
Study Start
March 10, 2023
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share