NCT05643742 A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
| NCT ID | NCT05643742 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CRISPR Therapeutics AG |
| Condition | B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2023-03-10 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Melanie Allen, M.Sc.
STUDY DIRECTOR
CRISPR Therapeutics
Frequently Asked Questions
Who can join the NCT05643742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05643742 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05643742 currently recruiting?
Yes, NCT05643742 is actively recruiting participants. Contact the research team at MedicalAffairs@crisprtx.com for enrollment information.
Where is the NCT05643742 trial being conducted?
This trial is being conducted at Westwood, United States, St Louis, United States, San Antonio, United States, Salt Lake City, United States and 3 additional locations.
Who is sponsoring the NCT05643742 clinical trial?
NCT05643742 is sponsored by CRISPR Therapeutics AG. The principal investigator is Melanie Allen, M.Sc. at CRISPR Therapeutics. The trial plans to enroll 120 participants.