A Phase 1/2 interventional study of DS3790a and Combination drug in Hematological Malignancies and B-cell Non-Hodgkin Lymphoma, sponsored by Daiichi Sankyo. Recruiting at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Daiichi Sankyo · Phase 1/2, Interventional, and Treatment
This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.
DS3790a may be effective in the treatment of patients with hematological malignancies. The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 420 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this trial, an individual must meet all the following criteria:
An individual who meets any of the following criteria will be excluded from participating in this trial:
Participants with hematological malignancies who received DS3790a monotherapy.
Drug: DS3790a
Participants with hematological malignancies who received DS3790a monotherapy.
Drug: DS3790a
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Drug: DS3790a · Drug: Combination drug
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Drug: DS3790a · Drug: Combination drug
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Drug: DS3790a · Drug: Combination drug
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Drug: DS3790a · Drug: Combination drug
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Drug: DS3790a · Drug: Combination drug
Participants with hematological malignancies who received standard of care (SoC).
Drug: Combination drug
Administered as specified in the protocol
Administered as specified in the protocol
Administered as specified in the protocol
Number of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological Malignancies
Adverse events (AEs) will be graded using NCI-CTCAE version 5.0.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2)
Complete Response (CR) is defined as participants with CR as measured by BICR assessment.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase)
Complete Response (CR) is defined as participants with CR as measured by investigator assessment.
Time frame: Baseline up to 5 years
Objective Response by Investigator Assessment In Participants With Hematological Malignancies
Objective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Complete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment.
Time frame: Baseline up to 5 years
Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Disease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment.
Time frame: Baseline up to 5 years
Duration of Complete Response and Duration of Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Duration of Complete Response (DoCR) is defined as the time from the date of first documentation of CR to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoCR will be calculated for responders (CR) only. Duration of Response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR) to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoR will be calculated for responders (CR or PR) only.
Time frame: Baseline up to 5 years
Time to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Time to Response (TTR) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of the first documentation of objective response (CR or PR) by investigator assessment. TTR will be calculated for responders (CR or PR) only.
Time frame: Baseline up to 5 years
Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Progression-free Survival (PFS) is defined as time from the date of the start of trial intervention or randomization if randomized, to the date of radiographic disease progression, defined as the first documented objective PD by investigator assessment or death due to any cause.
Time frame: Baseline up to 5 years
Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Overall Survival (OS) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of death due to any cause.
Time frame: Baseline up to 5 years
Plan to share: Yes — De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Sap, Icf
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