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Experimental lymphoma drug DS-3201b enters early human testing

NCT ID NCT02732275

Disease control Sponsor: Daiichi Sankyo Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an experimental drug called DS-3201b in about 100 adults with non-Hodgkin lymphoma whose cancer has come back or is not responding to current treatments. The main goals are to find a safe dose and see how the drug works in the body. The study also checks for side effects and looks at how well the drug might shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2016

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL) * Has relapsed from or is refractory to standard treatment or no standard treatment is available * Is the age of majority in their country (18 in the US and 20 in Japan) at the time of informed consent * Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Has at least one evaluable lesion site (not applicable for the DDI cohort) * Has preserved organ function based on baseline laboratory data at screening tests * If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug * Tumor biopsy collections: 1. willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline 2. \[US only\] willing to provide fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator \[Japan only\] fresh on-treatment tumor biopsy should be performed if deemed acceptable risk by the investigator 3. willing to provide optional fresh end-of-treatment biopsy For ATL subjects: * Has a positive test result for human T-lymphotropic virus type I antibody * Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic factor * Has diagnosis of relapse (including relapse after partial remission \[PR\]) or treatment-resistant ATL at the time of informed consent after prior treatment with at least 1 anti-cancer medication regimen Exclusion Criteria: * Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia. For DDI cohort, CTCL is not exclusionary. * Has a history or presence of central nervous system (CNS) involvement * Has a medical history, complication or other malignancy considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study * Has received drugs or other treatments not allowed by the protocol * History of treatment with other enhancer of zeste (EZH) inhibitors * Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days before scheduled dosing on Cycle 1 Day 1 * Is pregnant or breastfeeding * Is otherwise deemed ineligible to participate by the investigator or sub-investigator DDI Cohort Only: * Has received following medications within 14 days prior to study drug administration * Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp inhibitors, midazolam as well as digoxin

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Conditions

The condition(s) this trial relates to.

adult T-cell leukemia/lymphoma B-cell neoplasm Leukemia-Lymphoma, Adult T-Cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma non-Hodgkin lymphoma primary cutaneous T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma, malignant Non-Hodgkin lymphoma

Contacts and locations

Locations

  • City of Hope National Medical center

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Imamura General Hospital

    Kagoshima, Kagoshima-ken, 890-0064, Japan

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505, Japan

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Kumamoto University Hosipital

    Kumamoto, Kumamoto, 860-8556, Japan

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital

    Chūōku, Toyko, 104-0045, Japan

  • National Cancer Center Hospital East

    Kahiwa-shi, Chiba, 277-8577, Japan

  • The Institute of Medical Science, The University of Tokyo

    Minato-ku, Tokyo, 108-8639, Japan

  • The Ohio State University Wexner Medical Center and James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa, 903-0215, Japan

  • Weill Cornell Medicine

    New York, New York, 10021, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.