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

June 2, 2026 updated by: The Lymphoma Academic Research Organisation

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France, 94010
        • Recruiting
        • Hopital Henri Mondor
        • Principal Investigator:
          • François LEMONNIER, Doctor
        • Contact:
      • Dijon, France, 21000
        • Recruiting
        • CHU Dijon Bourgogne
        • Contact:
        • Principal Investigator:
          • Amandine DURAND, Doctor
      • La Tronche, France, 38700
        • Recruiting
        • CHU de GRENOBLE
        • Contact:
        • Principal Investigator:
          • Sylvain CARRAS, Doctor
      • Lille, France, 59037
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Gabriel BRISOU, Doctor
      • Montpellier, France, 34090
        • Recruiting
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Charles HERBAUX, Doctor
      • Nantes, France, 44093
      • Paris, France, 75475
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
        • Principal Investigator:
          • Catherine THIEBLEMONT, Professor
      • Pessac, France, 33604
      • Rennes, France, 35033
        • Recruiting
        • CHU Pontchaillou
        • Contact:
        • Principal Investigator:
          • Roch HOUOT, Professor
      • Rouen, France, 76038
      • Toulouse, France, 31059
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • CHU Brabois
        • Contact:
        • Principal Investigator:
          • Arnaud CAMPIDELLI, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
  2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
  3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells
  4. Performance Status 0, 1, or 2

  5. With aggressive large B-cell lymphoma, including:

    • diffuse large B-cell lymphoma
    • 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
  6. Available biopsy for centralized review
  7. 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
  8. 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)
  9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if > 60-year-old or Cockcroft-Gault if <60yo) >45 mL/min,

  10. 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))
  11. Patient covered by any social security system (France)
  12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators

  13. 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.

Exclusion Criteria:

  1. 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
  2. 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
  3. 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
  4. Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on room air
  5. Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)
  6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
  7. History of severe immediate hypersensitivity reaction to any of the agents used in this study
  8. Current treatment with strong CYP3A4/5 modulators (see appendix 13)
  9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
  10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
  11. Person deprived of his/her liberty by a judicial or administrative decision
  12. Person hospitalized without consent
  13. Adult person under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: golcadomide post CAR T-cells
0.3 mg - Per Os - every week - 6 months
Drug: golcadomide
golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166
Other Names:
  • BMS-986369
  • CC-99282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete metabolic response rate (CMR rate)
Time Frame: 3 months
efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: at 1 month, 3 months, 6 months, 1 year and 2 years, from CAR-T infusion
incidence of either a complete (CMR) or a partial (PMR) metabolic response per the Lugano Classification (Cheson 2014) as determined by study investigators
at 1 month, 3 months, 6 months, 1 year and 2 years, from CAR-T infusion
Objective response rate (ORR)
Time Frame: at 1 month and 3 months
determined by imaging central review
at 1 month and 3 months
Complete response rate (CRR)
Time Frame: at 1 Month, 6 Months, 1 year, and 2 years
percentage of complete response determined by investigator assessment classification
at 1 Month, 6 Months, 1 year, and 2 years
Duration of response (DR)
Time Frame: 2 years
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
2 years
Event-free survival (EFS)
Time Frame: 2 years
the time between CAR T-cells injection and death, disease progression, or start of subsequent new anti-lymphoma therapy including Stem Cell Transplant (SCT)
2 years
Progression-free survival (PFS)
Time Frame: 2 years
time from CAR T-cells injection to the first observation of documented disease progression/relapse (based on investigator disease assessment (INV)) or death
2 years
Time To Next anti-Lymphoma Treatment (TTNLT)
Time Frame: 2 years
from the date of CAR T-cells injection to the date of first documented administration of any new anti-lymphoma treatment
2 years
Overall survival (OS)
Time Frame: 2 years
from date of CAR T-cells injection to the date of death
2 years
Incidence of Adverse Events and Serious Adverse events
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Collaborators

Lymphoma Study Association

Investigators

  • Principal Investigator: Catherine THIEBLEMONT, Prof. Dr., Hôpital Saint-Louis
  • Principal Investigator: Gabriel BRISOU, Prof. Dr., Institut Paoli-Calmettes
  • Principal Investigator: François-Xavier GROS, Prof. Dr., University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARMOD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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