RecruitingPhase 1Phase 2NCT05643742

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


Sponsor

CRISPR Therapeutics AG

Enrollment

120 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR T-cell therapy called CTX112 — made from donor cells rather than the patient's own cells — in people with relapsed or treatment-resistant B-cell blood cancers such as B-cell lymphoma or leukemia. **You may be eligible if...** - You are 18 or older - You have a B-cell blood cancer that has come back or stopped responding to prior treatments - Your overall health is good (ECOG 0 or 1) - Your heart, kidney, liver, and lung function are acceptable - You agree to use contraception for at least 12 months after treatment **You may NOT be eligible if...** - You have had a prior bone marrow or stem cell transplant from a donor - Your cancer involves the brain or spinal cord (CNS involvement) - You have a history of seizures, stroke, dementia, or autoimmune brain disease - You have an active, uncontrolled bacterial, viral, or fungal infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCTX112

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


Locations(7)

University of Kansas

Westwood, Kansas, United States

Washington University

St Louis, Missouri, United States

SCRI

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Royal Prince Alfred

Camperdown, New South Wales, Australia

Alfred Health

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT05643742


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