B-cell Lymphoma study: CTX112
Official title A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
ClinicalTrials.gov ID: NCT05643742
What this study is testing
What is CTX112?
This is an investigational cell therapy being studied as a potential treatment for B-cell lymphoma. It is designed to use healthy donor T cells that have been edited in a lab to recognize and target B cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe CTX112 is and whether it works for people whose B‑cell cancers have come back or not responded to other treatments.
- Who it's for
- Adults who have relapsed or refractory B‑cell lymphoma or related cancers such as CLL, follicular, mantle cell, or large B‑cell lymphoma.
- What's involved
- Participants will receive CTX112 and attend scheduled clinic visits for monitoring and tests to track safety and response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Female people of childbearing potential and male people must agree to use acceptable method(s) of contraception from enrollment through at least 12...
You likely can't join if
- 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.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator...
See the full eligibility criteria
- 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.
- Female people of childbearing potential and male people must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion. Key
- 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.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- 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).
- 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.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Westwood, Kansas, United States
- St Louis, Missouri, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Camperdown, New South Wales, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Westwood, Kansas, United States; St Louis, Missouri, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States; Camperdown, New South Wales, Australia; Melbourne, Victoria, Australia and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.