Actively Recruiting
Golcadomide (BMS-986369) Post-CAR T-cell Therapy in Relapsed/Refractory Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Led by The Lymphoma Academic Research Organisation · Updated on 2026-06-04
65
Participants Needed
13
Research Sites
91 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
L
Lymphoma Study Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating golcadomide as a treatment after anti-CD19 CAR T-cell therapy in patients with aggressive large B-cell lymphoma, including types such as diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, and high-grade B-cell lymphoma. This open-label, multicenter phase 2 trial aims to estimate the effectiveness of golcadomide in improving complete metabolic response three months after CAR T-cell infusion in approximately 65 patients with a high risk of relapse. Participants will receive golcadomide orally at a dose of 0.3 mg weekly, starting five days after CAR T-cell infusion, continuing for 24 weeks across six cycles of 28 days. The study includes a safety analysis after the first three patients complete a treatment cycle or discontinue, to decide on continuing enrollment. The trial focuses on patients eligible for authorized anti-CD19 CAR T-cell therapy and monitors treatment effects over a two-year period. During the study, participants will undergo various assessments including imaging with 18FDG-PET before CAR T-cell therapy and evaluations of metabolic response at one month, three months, six months, and up to two years. Researchers will track response rates, duration of response, survival outcomes, and adverse events. The total participation includes treatment and follow-up for two years to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures
- Adult patients 18 years or older at the time of signing consent, no upper age limit
- Eligible for any authorized anti-CD19 CAR T-cell therapy
- Performance status 0, 1, or 2
- Diagnosed with aggressive large B-cell lymphoma including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, or high-grade B-cell lymphoma
- Available biopsy for centralized review
- Indication for CAR T-cell therapy as second to fourth line treatment validated by tumor board
- Total Metabolic Tumor Volume (TMTV) greater than 80 ml measured by PET before CAR T-cell procedure
- Creatinine clearance greater than 45 mL/min
- Adequate liver function with ALT/AST ≤3.0 x ULN (or ≤5.0 x ULN if liver involvement) and bilirubin ≤2.0 mg/dL (or ≤3.0 mg/dL with Gilbert's syndrome or liver involvement)
- Covered by social security system in France
- Understand and speak an official country language or have authorized translator
- For women of childbearing potential, agreement to abstain or use two contraception methods during treatment and for 28 days after last dose
You will not qualify if you...
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for 3 years or more
- Uncontrolled or IV-treated fungal, bacterial, viral, or other infections (simple urinary tract infection or bacterial pharyngitis allowed if responding to treatment)
- History of HIV or active hepatitis B or C infection unless cleared by guidelines
- Significant lung impairment with oxygen saturation below 92% on room air
- Significant cardiovascular disease including NYHA Class III/IV or recent serious cardiac events within 6 months
- Severe allergic reactions to study agents
- Current use of strong CYP3A4/5 modulators
- Pregnant, planning pregnancy, or breastfeeding women of childbearing potential
- Medical or psychiatric conditions interfering with study participation
- Person deprived of liberty by legal decision
- Person hospitalized without consent
- Adult under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive golcadomide 0.3 mg weekly starting 5 days after CAR T-cell therapy until day 166 post CAR T-cell administration.
Weekly visits for golcadomide administration
Duration - Up to 2 years
Participants are monitored for response to treatment and adverse events for up to 2 years after CAR T-cell infusion.
Visits at 1 month, 3 months, 6 months, 1 year, and 2 years post CAR T-cell infusion
Trial Site Locations
Total: 13 locations
1
Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
2
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
3
Chu de Grenoble
La Tronche, France, 38700
Actively Recruiting
4
Chru de Lille
Lille, France, 59037
Actively Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
6
Chu de Montpellier
Montpellier, France, 34090
Actively Recruiting
7
Chu de Nantes
Nantes, France, 44093
Actively Recruiting
8
Hopital Saint-Louis
Paris, France, 75475
Actively Recruiting
9
Chu de Bordeaux
Pessac, France, 33604
Actively Recruiting
10
Chu Pontchaillou
Rennes, France, 35033
Actively Recruiting
11
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
12
Iuct Oncopole
Toulouse, France, 31059
Actively Recruiting
13
Chu Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
S
Stéphanie DOYEN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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