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Lymphoma drug combo trial halted early – what we know

NCT ID NCT03769181

Disease control Sponsor: Sanofi 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tested two drugs, isatuximab and cemiplimab, together in 58 people with relapsed or refractory lymphoma. The goal was to see if the combination was safe and could shrink tumors. The study was terminated early, so while some safety and response data were collected, the full potential of this approach remains unclear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab and cemiplimab
What this could lead to
If successful, this combination could offer a new treatment option for people with certain types of lymphoma that have not responded to other therapies.
What could go wrong
The trial was terminated early, so results are limited. It is still early-stage research, and the combination may not prove effective or safe for broader use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

58 people

The number who actually took part.

Started

Dec 2018

Finished

Nov 2022

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

12 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: * Participants greater than or equal to (\>=) 12 years of age inclusive, at the time of signing the informed consent. * Disease location amenable to tumor biopsy at Baseline. * Measurable disease. * For Cohort A1 (cHL anti-programmed cell death protein 1/ligand 1 \[PD-1/PD-L1\] inhibitor naïve): Histologically confirmed advanced cHL that had relapsed or progressed after at least 3 lines of systemic therapy that included autologous hematopoietic stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedotin (BV). * For Cohort A2 (cHL anti-PD-1/PD-L1 inhibitor progressor): Histologically confirmed advanced cHL which had relapsed or progressed after one previous anti-PD-1/PD-L1 containing regimen as the most recent prior therapy but no more than 4 lines of previous chemotherapy including the anti-PD-1/PD-L1 containing regimen and documentation of benefit during or after the anti-PD-1/PD-L1 containing regimen within 4 months prior to initiation of investigational medicinal product. * For Cohort B (diffuse large B-cell lymphoma \[DLBCL\]): Histologically confirmed advanced DLBCL that had relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who were not eligible for auto-HSCT. * For Cohort C (peripheral T-cell lymphoma \[PTCL\]): Histologically confirmed advanced PTCL that had relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants were ineligible for auto-HSCT. * Body weight of greater than (\>) 45 kilograms for participants with age less than (\<)18 years. Exclusion criteria: * Prior exposure to agent that blocks CD38. * For participants with cHL (PD-1/PD-L1 naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1, PD-L2, CD137, cytotic T-lymphocyte-associated protein 4 or LAG-3. * Evidence of other immune related disease/conditions. * Had received a live-virus vaccination within 28 days of planned treatment start; seasonal flu vaccines that do not contain live virus are permitted. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \>=2. * Poor bone marrow reserve. * Poor organ function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

classic Hodgkin lymphoma diffuse large B-cell lymphoma lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma

Contacts and locations

Locations

  • Investigational Site Number :1580002

    Taichung, 40447, Taiwan

  • Investigational Site Number :2500001

    Villejuif, 94800, France

  • Investigational Site Number :2500002

    Nantes, 44093, France

  • Investigational Site Number :2500004

    Montpellier, 34295, France

  • Investigational Site Number :2500005

    Dijon, 21000, France

  • Investigational Site Number :2500007

    Pessac, 33600, France

  • Investigational Site Number :3800002

    Bologna, 40138, Italy

  • Investigational Site Number :3800003

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number :3800006

    Brescia, 25123, Italy

  • Investigational Site Number :4100001

    Gangnam-gu, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number :4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number :5280001

    Maastricht, 6229 HX, Netherlands

  • Investigational Site Number :5280002

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number :6200002

    Coimbra, 3000-075, Portugal

  • Investigational Site Number :6200003

    Porto, 4200, Portugal

  • Investigational Site Number :6200004

    Lisbon, 1649-035, Portugal

  • Investigational Site Number :7240002

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908, Spain

  • Investigational Site Number :7240003

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number :7240004

    Madrid / Madrid, Madrid, Comunidad de, 28040, Spain

  • Investigational Site Number :7240005

    Barcelona, Barcelona [Barcelona], 08036, Spain

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