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Hematological MalignanciesPhase 1/2NCT07220616

A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

A Phase 1/2 study testing DS3790a and Combination drug in people with Hematological Malignancies and B-cell Non-Hodgkin Lymphoma, run by Daiichi Sankyo at 8 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DS3790a and Combination drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
8 sitesin 4 countries
Study dates
16 Jan 2026to 30 Nov 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

8 sites in 4 countries

France3 sites, 3 recruiting

  • Research Site

    Lille, 59037

    Principal Investigator

    Recruiting

  • Research Site

    Pierre-Bénite, 69495

    Principal Investigator

    Recruiting

  • Research Site

    Villejuif, 94800

    Principal Investigator

    Recruiting

Other trials in France

Japan3 sites, 3 recruiting

  • Research Site

    Nagoya, 464-8681

    Principal Investigator

    Recruiting

  • Research Site

    Tokyo, 104-0045

    Principal Investigator

    Recruiting

  • Research Site

    Tokyo, 135-8550

    Principal Investigator

    Recruiting

Other trials in Japan

United States1 site, 1 recruiting

  • Research Site

    New York, New York, 10065

    Principal Investigator

    Recruiting

Other trials in United States

Italy1 site, 1 recruiting

  • Research Site

    Bologna, 40138

    Principal Investigator

    Recruiting

Other trials in Italy

About this study

Official title: A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC Targeting CD37, for Hematological Malignancies

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.

Read the detailed description

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.

Being tested
DS3790a, Combination drug
Keywords
Hematological Malignancies, DS3790a, B-cell non-Hodgkin lymphoma
Medical subject headings
Hematologic Neoplasms, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS3790aDrug

    Administered as specified in the protocol

  • Combination drugDrug

    Administered as specified in the protocol

  • Combination drugDrug

    Administered as specified in the protocol

Study groups in NCT07220616
Study groupRoleWhat they receive
Monotherapy Dose Escalation PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy.
Receives: Drug: DS3790a
Monotherapy Dose Expansion PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy.
Receives: Drug: DS3790a
Cohort A Combination Dose-escalation PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Receives: Drug: DS3790a; Drug: Combination drug
Cohort A Randomization/Optimization PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Receives: Drug: DS3790a; Drug: Combination drug
Cohort A Phase 2ExperimentalParticipants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Receives: Drug: DS3790a; Drug: Combination drug
Cohort B Combination Dose-escalation PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Receives: Drug: DS3790a; Drug: Combination drug
Cohort B Randomization/Optimization PhaseExperimentalParticipants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
Receives: Drug: DS3790a; Drug: Combination drug
Standard of CareActive comparatorParticipants with hematological malignancies who received standard of care (SoC).
Receives: Drug: Combination drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 5 years

  2. 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.

    Measured: Baseline up to 5 years

  3. 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.

    Measured: Baseline up to 5 years

Secondary outcomes (7)

  1. 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.

    Measured: Baseline up to 5 years

  2. 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.

    Measured: Baseline up to 5 years

  3. 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.

    Measured: Baseline up to 5 years

  4. 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.

    Measured: Baseline up to 5 years

  5. 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.

    Measured: Baseline up to 5 years

  6. 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.

    Measured: Baseline up to 5 years

  7. 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.

    Measured: Baseline up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2025
  2. Study start16 Jan 2026
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220616
Sponsor's protocol ID
DS3790-076
Other IDs
2025-522595-87-00, 2025
Status last verified
Aug 2026
First submitted
21 Oct 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DS3790a and Combination drug in people with Hematological Malignancies and B-cell Non-Hodgkin Lymphoma, run by Daiichi Sankyo at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Japan, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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