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

ConditionsB-cell Lymphoma Non-Hodgkin Lymphoma B-cell Malignancy Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Large B-cell Lymphoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCRISPR Therapeutics AG

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

CTX112

Treatment groups

120 Participants

are divided into 1 treatment group

Locations

Australia

Royal Prince Alfred2050, CamperdownNew South Wales, Australia

Alfred Health3004, MelbourneVictoria, Australia

Sir Charles Gairdner Hospital6009, NedlandsWestern Australia, Australia

United States

University of Kansas66205, WestwoodKansas, United States

Sponsors and collaborators

CRISPR Therapeutics AG

Lead sponsor

Source ClinicalTrials.gov