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Diffuse Large B-cell Lymphoma RefractoryPhase 2NCT06271057

Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

A Phase 2 study testing golcadomide in people with Diffuse Large B-cell Lymphoma Refractory and Refractory Primary Mediastinal Large B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 13 sites in France.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
golcadomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
13 sitesFrance
Study dates
14 Jun 2024to 31 Dec 2028
Phase
Phase 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

Who may be able to join

  • Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
  • Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
  • Eligible for any commercialized market authorized anti-CD19 CAR T-cells
  • Performance Status 0, 1, or 2
  • With aggressive large B-cell lymphoma, including:
  • diffuse large B-cell lymphoma
Show all 20Show fewer
  • Primary mediastinal B-cell lymphoma
  • Any transformed follicular or marginal zone lymphoma
  • high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma
  • Available biopsy for centralized review
  • With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment
  • Total MetabolicTumor Volume (TMTV) > 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +/- 4 days before lymphodepletion)
  • Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if > 60-year-old or Cockcroft-Gault if <60yo) >45 mL/min,
  • Adequate hepatic function:
  • aspartate aminotransferase/alanine aminotransferase (ALT/AST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT/AST must be ≤ 5.0 x ULN)
  • Serum total bilirubin ≤ 2.0 mg/dL (34 μmol/L) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg/dL (51 μmol/L))
  • Patient covered by any social security system (France)
  • Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators
  • Contraception:
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.

Who cannot join

  • History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
  • Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor
  • History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
  • Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on room air
  • Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
Show all 13Show fewer
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study
  • Current treatment with strong CYP3A4/5 modulators (see appendix 13)
  • Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
  • Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
  • Person deprived of his/her liberty by a judicial or administrative decision
  • Person hospitalized without consent
  • Adult person under legal protection

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stéphanie DOYEN contact

+33 4 27 01 27 36

stephanie.doyen@lysarc.org

13 sites in 1 country

France13 sites, 13 recruiting

  • Hopital Henri Mondor

    Créteil, 94010

    François LEMONNIER, francois.lemonnier@aphp.fr

    François LEMONNIER, Doctor

    Recruiting

  • Chu Dijon Bourgogne

    Dijon, 21000

    Amandine DURAND, amandine.durand@chu-dijon.fr

    Amandine DURAND, Doctor

    Recruiting

  • Chu de Grenoble

    La Tronche, 38700

    Sylvain CARRAS, scarras@chu-grenoble.fr

    Sylvain CARRAS, Doctor

    Recruiting

  • Chru de Lille

    Lille, 59037

    Franck MORSCHHAUSER, franck.morschhauser@chu-lille.fr

    Franck MORSCHHAUSER, Professor

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Gabriel BRISOU, brisoug@ipc.unicancer.fr

    Gabriel BRISOU, Doctor

    Recruiting

  • Chu de Montpellier

    Montpellier, 34090

    Charles HERBAUX, c-herbaux@chu-montpellier.fr

    Charles HERBAUX, Doctor

    Recruiting

  • Chu de Nantes

    Nantes, 44093

    Benoit TESSOULIN, benoit.tessoulin@chu-nantes.fr

    Benoit TESSOULIN, Doctor

    Recruiting

  • Hopital Saint-Louis

    Paris, 75475

    Catherine THIEBLEMONT, catherine.thieblemont@aphp.fr

    Catherine THIEBLEMONT, Professor

    Recruiting

  • Chu de Bordeaux

    Pessac, 33604

    François-Xavier GROS, francois-xavier.gros@chu-bordeaux.fr

    François-Xavier GROS, Doctor

    Recruiting

  • Chu Pontchaillou

    Rennes, 35033

    Roch HOUOT, roch.houot@chu-rennes.fr

    Roch HOUOT, Professor

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Fabrice JARDIN, fabrice.jardin@chb.unicancer.fr

    Fabrice JARDIN, Professor

    Recruiting

  • Iuct Oncopole

    Toulouse, 31059

    Lucie OBERIC, oberic.lucie@iuct-oncopole.fr

    Lucie OBERIC, Doctor

    Recruiting

  • Chu Brabois

    Vandœuvre-lès-Nancy, 54511

    Arnaud CAMPIDELLI, A.CAMPIDELLI@chru-nancy.fr

    Arnaud CAMPIDELLI, Doctor

    Recruiting

Other trials in France

About this study

Official title: Golcadomide (BMS-986369) Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.

Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.

Read more

The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.

The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.

Being tested
golcadomide
Keywords
eligible for CAR T-cells therapy

What participants receive

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

  • golcadomideDrug

    Also called BMS-986369, CC-99282

    golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166

Study groups in NCT06271057
Study groupRoleWhat they receive
golcadomide post CAR T-cellsExperimental0.3 mg - Per Os - every week - 6 months
Receives: Drug: golcadomide

What is being measured

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

  1. Complete metabolic response rate (CMR rate)

    efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion

    Measured: 3 months

Secondary outcomes (9)

  1. Objective response rate (ORR)

    incidence of either a complete (CMR) or a partial (PMR) metabolic response per the Lugano Classification (Cheson 2014) as determined by study investigators

    Measured: at 1 month, 3 months, 6 months, 1 year and 2 years, from CAR-T infusion

  2. Objective response rate (ORR)

    determined by imaging central review

    Measured: at 1 month and 3 months

  3. Complete response rate (CRR)

    percentage of complete response determined by investigator assessment classification

    Measured: at 1 Month, 6 Months, 1 year, and 2 years

  4. Duration of response (DR)

    time from attainment of PMR or CMR to the date of first documented disease progression/relapse (based on investigator disease assessment (INV)) or death from any cause

    Measured: 2 years

  5. Event-free survival (EFS)

    the time between CAR T-cells injection and death, disease progression, or start of subsequent new anti-lymphoma therapy including Stem Cell Transplant (SCT)

    Measured: 2 years

  6. Progression-free survival (PFS)

    time from CAR T-cells injection to the first observation of documented disease progression/relapse (based on investigator disease assessment (INV)) or death

    Measured: 2 years

  7. Time To Next anti-Lymphoma Treatment (TTNLT)

    from the date of CAR T-cells injection to the date of first documented administration of any new anti-lymphoma treatment

    Measured: 2 years

  8. Overall survival (OS)

    from date of CAR T-cells injection to the date of death

    Measured: 2 years

  9. Incidence of Adverse Events and Serious Adverse events

    Measured: 2 years

Timeline

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

  1. First posted21 Feb 2024
  2. Study start14 Jun 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271057
Sponsor's protocol ID
CARMOD
Status last verified
Jun 2026
First submitted
14 Feb 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing golcadomide in people with Diffuse Large B-cell Lymphoma Refractory and Refractory Primary Mediastinal Large B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 13 sites in France.

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

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. 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 phase mean?

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 Stéphanie DOYEN (+33 4 27 01 27 36, stephanie.doyen@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete metabolic response rate (CMR rate) (time frame: 3 months). 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 NCT06271057.

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 4 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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