B-cell LymphomaPhase 1/2NCT05643742
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
A Phase 1/2 study testing CTX112 in people with B-cell Lymphoma and Non-Hodgkin Lymphoma, run by CRISPR Therapeutics AG at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy
- What is being tested?
- CTX112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Mar 2023to Feb 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
- Recruiting
SCRI
San Antonio, Texas, 78229
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
University of Kansas
Westwood, Kansas, 66205
Australia3 sites, 3 recruiting
- Recruiting
Royal Prince Alfred
Camperdown, New South Wales, 2050
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official title: 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
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.
Read the detailed description
This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
- Conditions
- B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy, Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma, Mantle Cell Lymphoma
- Being tested
- CTX112
- Keywords
- CAR T, Non-Hodgkin Lymphoma (NHL), Lymphoma, Allogeneic
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX112Biological
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
| Study group | Role | What they receive |
|---|---|---|
| CTX112 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. Receives: Biological: CTX112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Measured: From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
Measured: From CTX112 infusion up to 60 months post-infusion
Secondary outcomes (4)
Duration of Response
Duration of Response (DOR) will only be reported for subjects who have had CR/PR events
Measured: From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
Duration of Clinical Benefit (DOCB)
Measured: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
Progression Free Survival
Measured: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Measured: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start10 Mar 2023
- Primary completionJan 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CRISPR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Allen, M.Sc., Study director, CRISPR Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643742
- Sponsor's protocol ID
- CRSP-ONC-006
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2022
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05643742
- Acronym / sponsor ID
- CRSP-ONC-006
- Conditions
- B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy, Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma, Mantle Cell Lymphoma
- Keywords
- CAR T, Non-Hodgkin Lymphoma (NHL), Lymphoma, Allogeneic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CRISPR Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTX112 | Experimental | Biological: CTX112Administered by IV infusion following lymphodepleting chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX112CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components) | Biological | CTX112 |
Primary outcome
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
4 secondary outcomes
Duration of Response
Time frame: From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
Duration of Clinical Benefit (DOCB)
Time frame: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
Progression Free Survival
Time frame: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Time frame: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Allen, M.Sc. study director
CRISPR Therapeutics
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTX112 in people with B-cell Lymphoma and Non-Hodgkin Lymphoma, run by CRISPR Therapeutics AG at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (+1 (877) 214-4634, MedicalAffairs@crisprtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities (time frame: From CTX112 infusion up to 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.