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Clinical Trials in the USA / NCT05643742
Recruiting Phase 1/2

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

NCT05643742 · tracked via the Priya Life Science USA tracker
Sponsor
CRISPR Therapeutics AG
Phase
Phase 1/2
Started
2023-03-10
Last updated
2025-11-14

Condition(s) studied

B-cell LymphomaNon-Hodgkin LymphomaB-cell MalignancyChronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Follicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaLarge B-cell Lymphoma

Investigational drug(s) / intervention(s)

CTX112

CTX112: CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Age ≥18 years. 2. Refractory or relapsed B cell malignancy. 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 CTX112 infusion. Key Exclusion Criteria: 1. Prior allogeneic hematopoietic stem cell transplant (HSCT). 2. Active or history of central nervous system (CNS) involvement by malignancy. 3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. 4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives. 5. Active HIV, hepatitis B virus or hepatitis C virus infection. 6. 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). 7. 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. 8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. Women who are pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
University of Kansas Westwood Kansas Recruiting
Washington University St Louis Missouri Recruiting
SCRI San Antonio Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Royal Prince Alfred Camperdown New South Wales Recruiting
Alfred Health Melbourne Victoria Recruiting
Sir Charles Gairdner Hospital Nedlands Western Australia Recruiting

More CRISPR Therapeutics AG trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05643742 on ClinicalTrials.gov ↗ ← All trials in the USA