B-cell MalignancyPhase 1/2NCT04035434

A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

A Phase 1/2 study testing CTX110 in people with B-cell Malignancy and Non-Hodgkin Lymphoma, run by CRISPR Therapeutics AG at 33 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 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 Malignancy, Non-Hodgkin Lymphoma, B-cell Lymphoma
What is being tested?: CTX110
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 33 sitesin 6 countries
Study dates: 22 Jul 2019to 4 Oct 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
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 CTX110 infusion.

Who cannot join

For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
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.
Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.

Show all 9Show fewer

For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 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

33 sites in 6 countries.

Country

City, postcode or hospital

33 sites in 6 countries

United States21 sites

Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Insitute
Buffalo, New York, 14203
University of Chicago
Chicago, Illinois, 60637
Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
Mayo Clinic
Jacksonville, Florida, 32224
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536
Cedars Sinai
Los Angeles, California, 90048
University of Minnesota
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Weill Cornell Medical College / New York Presbyterian Hospital
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
Texas Transplant Institute
San Antonio, Texas, 78229
UCSF Medical Center
San Francisco, California, 94143
Swedish Cancer Institute
Seattle, Washington, 98104
Washington University
St Louis, Missouri, 63130
University of Kansas
Westwood, Kansas, 66205

Other trials in United States

Australia3 sites

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050

Other trials in Australia

France3 sites

CHU de Lille
Lille, 59000
Institut Paoli-Calmettes
Marseille, 13009
Hôpital Saint Antoine
Paris, 75012

Other trials in France

Spain3 sites

Hospital Clínic de Barcelona
Barcelona, 08036
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Salamanca
Salamanca, 37007

Other trials in Spain

Germany2 sites

University of Hamburg
Hamburg, 20148
University Hospital Würzburg
Würzburg, 97080

Other trials in Germany

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Read the detailed description

The study may enroll up to 227 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors 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 Malignancy, Non-Hodgkin Lymphoma, B-cell Lymphoma, Adult B Cell ALL
Being tested: CTX110
Keywords: CAR T, Non-Hodgkin Lymphoma, NHL, Lymphoma, Allogeneic, Leukemia
Medical subject headings: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Burkitt Lymphoma, Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTX110Biological
CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Study groups in NCT04035434
Study group	Role	What they receive
CTX110	Experimental	Administered by IV infusion following lymphodepleting chemotherapy. Receives: Biological: CTX110

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment [e.g., 1 mg/kg/day], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Measured: Up to 28 days
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Measured: Up to 5 years

Secondary outcomes (9)

Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Measured: Up to 5 years
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation.
Measured: Up to 5 years
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation.
Measured: Up to 5 years
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation.
Measured: Up to 5 years
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Measured: Up to 5 years
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities.
Measured: Up to 5 years
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level.
Measured: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion.
Measured: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 20194 Oct 2024

First posted29 Jul 2019
Study start22 Jul 2019
Primary completion4 Oct 2024
Study completion4 Oct 2024

Why it stopped: Patients to be followed up in the CRSP-ONC-LTF study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for B-cell MalignancyStudies 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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04035434
Sponsor's protocol ID: CRSP-ONC-001
Status last verified: Oct 2025
First submitted: 22 Jul 2019
Last updated: 24 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

McGuirk JP, Ghobadi A, Bachier CR, Shaughnessy PJ, Awan FT, Maakaron JE, Bishop MR, Ho PJ, Tam CS, Dickinson MJ, Darrah JM, Waller EK, Murthy HS, Ross A, Williams LM, Pan C, Stevens WN, Serwer L, Nguyen T, Terrett J, Kalaitzidis D, Ma A, Xu H, Benton MD, Weaver A, Cohen SB, Maziarz RT, Cheah CY. Safety and efficacy of allogeneic CD19-directed CAR-T therapy CTX110 in relapsed/refractory B-cell non-Hodgkin lymphoma. Blood Adv. 2026 May 5:bloodadvances.2026020123. doi: 10.1182/bloodadvances.2026020123. Online ahead of print.
PubMed 42085626

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
ClinicalTrials.gov ID: NCT04035434
Acronym / sponsor ID: CRSP-ONC-001
Conditions: B-cell Malignancy, Non-Hodgkin Lymphoma, B-cell Lymphoma, Adult B Cell ALL
Keywords: CAR T, Non-Hodgkin Lymphoma, NHL, Lymphoma, Allogeneic, Leukemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patients to be followed up in the CRSP-ONC-LTF study
Enrolment: 93 participants (actual)
Lead sponsor: CRISPR Therapeutics AGIndustry (pharma, biotech, devices)
Study start: 22 Jul 2019 (actual)
Primary completion: 4 Oct 2024 (actual)
Study completion: 4 Oct 2024 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 24 Oct 2025

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 CTX110 in subjects with relapsed or refractory B-cell malignancies.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CTX110	Experimental	Biological: CTX110Administered 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)

For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
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 CTX110 infusion.

Key exclusion criteria (9 listed)

For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
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.
Positive for HIV, or active 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
CTX110CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components	Biological	CTX110

Primary outcome

Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
Time frame: Up to 28 days
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment [e.g., 1 mg/kg/day], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
Time frame: Up to 5 years
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.

9 secondary outcomes

Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
Time frame: Up to 5 years
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
Time frame: Up to 5 years
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
Time frame: Up to 5 years
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
Time frame: Up to 5 years
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
Time frame: Up to 5 years
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Time frame: Up to 5 years
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Time frame: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Time frame: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
Time frame: Up to 5 years

Results and safety

Results posted to the registry on 24 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: NHL: Cohort A: Dose Level (DL) 1 (3×10^7 CAR+ T Cells)	3	0
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)	3	0
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)	6	0
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)	6	0
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)	10	0
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)	4	0
Phase 2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)	0	0
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)	1	0
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)	5	0
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)	5	0
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)	4	0
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)	5	0
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)	7	0

Primary outcome: Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population

Time frame: Up to 28 days. Count of participants. Unit: Participants

Measure	Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) n = 3	Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) n = 3	Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) n = 6	Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) n = 6	Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) n = 10	Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) n = 4	Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) n = 1	Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) n = 5	Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) n = 5	Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) n = 4	Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) n = 5	Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) n = 7
Value	0	0	0	0	1	0	0	0	0	0	0	0

Population analysed: DLT Evaluable Set comprised of participants who received CTX110 and are followed for at least 28 days post-infusion or withdraw consent after experiencing a DLT.

Primary outcome: Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population

Time frame: Up to 5 years. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) n = 23	Phase 2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) n = 8
Value	60.9 (38.5 to 80.3)	75.0 (34.9 to 96.8)

Population analysed: Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)	3 of 3 (100%)	3 of 3 (100%)	3 of 3
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)	1 of 6 (16.7%)	6 of 6 (100%)	4 of 11
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)	1 of 6 (16.7%)	6 of 6 (100%)	3 of 6
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)	5 of 10 (50%)	10 of 10 (100%)	9 of 10
Phase 1/2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)	8 of 35 (22.9%)	34 of 35 (97.1%)	21 of 35
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)	1 of 5 (20%)	5 of 5 (100%)	3 of 5
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)	4 of 5 (80%)	5 of 5 (100%)	4 of 5
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)	3 of 5 (60%)	5 of 5 (100%)	2 of 5
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)	1 of 7 (14.3%)	7 of 7 (100%)	1 of 7

Limitations and caveats (from the sponsor): Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42085626McGuirk JP, Ghobadi A, Bachier CR, Shaughnessy PJ, Awan FT, Maakaron JE, Bishop MR, Ho PJ, Tam CS, Dickinson MJ, Darrah JM, Waller EK, Murthy HS, Ross A, Williams LM, Pan C, Stevens WN, Serwer L, Nguyen T, Terrett J, Kalaitzidis D, Ma A, Xu H, Benton MD, Weaver A, Cohen SB, Maziarz RT, Cheah CY. Safety and efficacy of allogeneic CD19-directed CAR-T therapy CTX110 in relapsed/refractory B-cell non-Hodgkin lymphoma. Blood Adv. 2026 May 5:bloodadvances.2026020123. doi: 10.1182/bloodadvances.2026020123. Online ahead of print.
Individual participant dataSharing planned: No

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4SCAR19U T Cells Targeting B Cell Malignancies
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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. This study is not recruiting at the moment.

Annie Weaver, PhD study director

CRISPR Therapeutics

33 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CTX110 in people with B-cell Malignancy and Non-Hodgkin Lymphoma, run by CRISPR Therapeutics AG at 33 sites in 6 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: stopped early, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Australia, France, Spain, Germany and 1 more country. 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?

Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population (time frame: Up to 28 days). 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?

On the ClinicalTrials.gov record for NCT04035434, which also lists 1 linked publication.

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 24 Oct 2025.