Recruiting
Phase 1
Phase 2

DS3790a

Sponsor:

Daiichi Sankyo

Code:

NCT07220616

Conditions

Hematological Malignancies

B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DS3790a

Combination drug

Combination drug

Study Details

Brief summary:

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.

Conditions

Hematological Malignancies

B-cell Non-Hodgkin Lymphoma

Study ID

NCT07220616

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

To be eligible to participate in this trial, an individual must meet all the following criteria:

1. Sign and date the ICF, prior to the start of any trial-specific procedures.
2. Adults >=18 years at the time the ICF is signed.
3. History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.
4. NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.
5. ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.
6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as specified in the protocol.
7. Has an LVEF >=50% by either an ECHO or MUGA within 28 days before the trial starts.
8. Life expectancy of at least 3 months.
9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.
11. A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.

An individual who meets any of the following criteria will be excluded from participating in this trial:

1. Prior Allo-SCT.
2. Prior solid organ transplantation.
3. Inadequate washout period before initiation of trial intervention as specified in the protocol.
4. Evidence of brain or leptomeningeal disease (spinal cord or CNS metastases) based on history and physical examination, unless treated and with radiologically documented lack of progression within 4 weeks prior to initiation of trial intervention.
5. Uncontrolled or significant cardiovascular disease as specified in the protocol.
6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
7. Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement, or prior pneumonectomy.
9. Has been diagnosed with another malignancy within the previous 3 years.
10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to NCI-CTCAE Version 5.0, Grade <=1 or baseline.
11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
12. Has active or uncontrolled HBV, HCV, or HIV infections.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Escalation Phase

Participants with hematological malignancies who received DS3790a monotherapy.

experimental: Monotherapy Dose Expansion Phase

Participants with hematological malignancies who received DS3790a monotherapy.

experimental: Cohort A Combination Dose-escalation Phase

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

experimental: Cohort A Randomization/Optimization Phase

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

experimental: Cohort A Phase 2

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

experimental: Cohort B Combination Dose-escalation Phase

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

experimental: Cohort B Randomization/Optimization Phase

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

active comparator: Standard of Care

Participants with hematological malignancies who received standard of care (SoC).

Interventions

DS3790a

Administered as specified in the protocol

Combination drug

Administered as specified in the protocol

Combination drug

Administered as specified in the protocol

Primary outcome measure

  • 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 [ 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) [ Time Frame: Baseline up to 5 years ]
  • Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase) [ Time Frame: Baseline up to 5 years ]

Central Contacts and Locations

Central contacts

Daiichi Sankyo Contact for Clinical Trial Information

908-992-6400CTRinfo_us@daiichisankyo.com

Locations

Research Site

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

Daiichi Sankyo

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Hematological Malignancies
  • DS3790a
  • B-cell non-Hodgkin lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Daiichi Sankyo on 2026-08-24.