18 and older, any sex, with B-cell Malignancy or Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL PopulationPrimary· 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 signific
Group
Value
95% CI
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
0
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
0
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
0
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL PopulationPrimary· 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.
Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL PopulationSecondary· Up to 5 years
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
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
25.0
0.6 – 80.6
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
40.0
5.3 – 85.3
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
85.7
42.1 – 99.6
Dose Escalation and Expansion Phase 1: Duration of Response in NHL PopulationSecondary· Up to 5 years
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.
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL PopulationSecondary· Up to 5 years
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.
Group
Value
95% CI
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL PopulationSecondary· Up to 5 years
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.
Group
Value
95% CI
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL PopulationSecondary· Up to 5 years
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.
Group
Value
95% CI
Phase1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
4
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
5
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
7
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL PopulationSecondary· Up to 5 years
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, Hyperk
Lymphocyte count decreased
Group
Value
95% CI
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
0
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
0
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
1
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL PopulationSecondary· 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
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.
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL PopulationSecondary· 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
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.
Day 1 pre-infusion
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
13.43
± 21.067
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
3.29
± 0.872
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
2.90
± 0.000
Day 1 post-infusion
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
781.86
± 1395.907
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
1983.57
± 1677.746
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
602.75
± 521.357
Day 2
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
4.20
± 2.252
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
93.47
± 149.220
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
18.13
± 17.532
Day 3
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
13.46
± 14.905
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
20.47
± 25.356
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
7.95
± 4.705
Day 5
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
28.65
± 36.011
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
42.37
± 47.444
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
62.85
± 124.743
Day 8
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
71.30
± 118.215
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
16846.17
± 33459.507
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
15941.89
± 30200.959
Day 10
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
226.32
± 290.508
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
26.17
± 41.517
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
14177.59
± 23256.089
Day 14
Group
Value
95% CI
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
1040.13
± 1466.869
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
2.90
± 0.000
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
380.29
± 924.424
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL PopulationSecondary· Up to 5 years
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.
Group
Value
95% CI
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CRISPR Therapeutics AG
Last refreshed: 24 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04035434.