NCT05643742 · CRISPR Therapeutics AG
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals, Phase 1/2 study evaluating the safety and effectiveness of CTX112™ in subjects with relapsed or refractory B-cell malignancies.
View original scientific description
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.
Interventions
BIOLOGICAL
CTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Primary outcome measures
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Time frame: From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
Time frame: From CTX112 infusion up to 60 months post-infusion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Westwood, Kansas
- St Louis, Missouri
- San Antonio, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations