A Phase 1/2 interventional study of CT204V-CD19 × CD20 in Relapsed or Refractory B-Cell Malignancies, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CT204V-CD19 × CD20, a dual targeting in vivo gene therapy generating anti-CD19/CD20 CAR-T cells in participants with R/R B-cell malignancies.
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive CT204V-CD19 × CD20, an In Vivo Lentiviral Vector Gene Therapy, generating dual targeting anti-CD19/CD20 Chimeric Antigen Receptor (CAR)-T cells.
Drug: CT204V-CD19 × CD20
Experimental
Also known as: CT204V
Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Incidence and severity of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Time frame: Up to 15 years
Number of Dose-Limiting Toxicities (DLTs) events during dose escalation, Phase 1 of the study.
Incidence of Dose-Limiting Toxicities (DLTs) during dose escalation, Phase 1 of the study.
Time frame: Up to 28 days.
Number of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.
Incidence of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.
Time frame: Up to 1 year.
Number of AEs leading to death, Phase 1 of the study.
Incidence of AEs leading to death, Phase 1 of the study.
Time frame: Up to 15 years
Number of AESI (adverse events of special interest), Phase 1 of the study.
Incidence of AESI (adverse events of special interest), Phase 1 of the study.
Time frame: Up to 15 years
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
To assess the efficacy based on ORR (CR+PR) events.
Time frame: Up to 24 months.
Complete Response (CR) rate, Phase 2 of the study.
To assess the efficacy based on CR rate.
Time frame: Up to 24 months.
Best Overall Response (BOR), Phase 2 of the study.
To assess the efficacy based on BOR rate.
Time frame: Up to 24 months.
Duration of Response (DoR), Phase 2 of the study.
To assess the efficacy based on DoR rate.
Time frame: Up to 24 months.
Duration of Complete Response (DoCR), Phase 2 of the study.
To assess the efficacy based on DoCR rate.
Time frame: Up to 24 months.
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study.
To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 1 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 1 of the study.
Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 1 of the study.
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.
Time frame: Up to 24 months post-infusion.
Frequency and severity of AEs/SAEs
To further characterize the safety of CT204V with selected prophylaxis regimen.
Time frame: Up to 15 years
Complete Response (CR) rate, Phase 1 of the study.
To evaluate the preliminary antitumor activity of CT204V per CR rate, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 1 of the study.
To evaluate the preliminary antitumor activity of CT204V based on BOR, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Duration of Response (DoR), Phase 1 of the study.
To evaluate the preliminary antitumor activity of CT204V based on DoR. as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 1 of the study.
To evaluate the preliminary antitumor activity ofCT204V based on DoCR, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 1 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 1 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 1 of the study.
Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Cmax/Clast, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 1 of the study.
Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Tmax/Tlast.
Time frame: Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 2 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.
Time frame: Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 1 of the study.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 2 of the study.
Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, central read.
Time frame: Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 2 of the study.
To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, central read.
Time frame: Up to 24 months post-infusion.
Complete Response (CR) rate, Phase 2 of the study.
To evaluate the preliminary antitumor activity of CT204V per CR rate, central read.
Time frame: Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 2 of the study.
To evaluate the preliminary antitumor activity of CT204V based on BOR, central read.
Time frame: Up to 24 months post-infusion.
Duration of Response (DoR), Phase 2 of the study.
To evaluate the preliminary antitumor activity of CT204V based on DoR, central read.
Time frame: Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 2 of the study.
To evaluate the preliminary antitumor activity ofCT204V based on DoCR, central read.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 2 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, central read.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 2 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, central read.
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 2 of the study.
Quantification of CT204V CAR transgene levels in peripheral blood per CAR, transgene PK parameter Cmax/Clast, central read
Time frame: Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 2 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.
Time frame: Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 2 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, central read.
Time frame: Up to 24 months post-infusion.
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, central read.
Time frame: Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 2 of the study.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, central read.
Time frame: Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 1 of the study.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, as assessed by the investigator.
Time frame: Up to 24 months post-infusion.
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2029, 35 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.