A Modular, Phase I/II Study to Evaluate CT204V-CD19 x CD20 in Participants With Relapsed or Refractory B-Cell Malignancies.
NCT07932496, Phase 1, Phase 2, Not yet recruiting, AstraZeneca
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Modular, Phase I/II Study to Evaluate CT204V-CD19 x CD20 in Participants With Relapsed or Refractory B-Cell Malignancies. | ClinicalTrials.gov |
| NCT number | NCT07932496 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | AstraZeneca | ClinicalTrials.gov |
| Conditions | Relapsed or Refractory B-Cell Malignancies | ClinicalTrials.gov |
| Interventions | CT204V-CD19 × CD20 | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study. | Up to 15 years | Incidence and severity of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study. | ClinicalTrials.gov |
| Primary | Number of Dose-Limiting Toxicities (DLTs) events during dose escalation, Phase 1 of the study. | Up to 28 days. | Incidence of Dose-Limiting Toxicities (DLTs) during dose escalation, Phase 1 of the study. | ClinicalTrials.gov |
| Primary | Number of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study. | Up to 1 year. | Incidence of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study. | ClinicalTrials.gov |
| Primary | Number of AEs leading to death, Phase 1 of the study. | Up to 15 years | Incidence of AEs leading to death, Phase 1 of the study. | ClinicalTrials.gov |
| Primary | Number of AESI (adverse events of special interest), Phase 1 of the study. | Up to 15 years | Incidence of AESI (adverse events of special interest), Phase 1 of the study. | ClinicalTrials.gov |
| Primary | Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study. | Up to 24 months. | To assess the efficacy based on ORR (CR+PR) events. | ClinicalTrials.gov |
| Primary | Complete Response (CR) rate, Phase 2 of the study. | Up to 24 months. | To assess the efficacy based on CR rate. | ClinicalTrials.gov |
| Primary | Best Overall Response (BOR), Phase 2 of the study. | Up to 24 months. | To assess the efficacy based on BOR rate. | ClinicalTrials.gov |
| Primary | Duration of Response (DoR), Phase 2 of the study. | Up to 24 months. | To assess the efficacy based on DoR rate. | ClinicalTrials.gov |
| Primary | Duration of Complete Response (DoCR), Phase 2 of the study. | Up to 24 months. | To assess the efficacy based on DoCR rate. | ClinicalTrials.gov |
| Secondary | Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Viral vector PK parameter AUClast, Phase 1 of the study. | Up to 24 months post-infusion. | Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 1 of the study. | Up to 24 months post-infusion. | Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Incidence of Anti-Drug Antibodies (ADA), Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Frequency and severity of AEs/SAEs | Up to 15 years | To further characterize the safety of CT204V with selected prophylaxis regimen. | ClinicalTrials.gov |
| Secondary | Complete Response (CR) rate, Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the preliminary antitumor activity of CT204V per CR rate, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Best Overall Response (BOR), Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the preliminary antitumor activity of CT204V based on BOR, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Duration of Response (DoR), Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the preliminary antitumor activity of CT204V based on DoR. as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Duration of Complete Response (DoCR), Phase 1 of the study. | Up to 24 months post-infusion. | To evaluate the preliminary antitumor activity ofCT204V based on DoCR, as assessed by the investigator. | ClinicalTrials.gov |
| Secondary | Viral vector PK parameter Cmax/Clast, Phase 1 of the study. | Up to 24 months post-infusion. | Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, as assessed by the investigator. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)