Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

Starting soon · Phase 1/Phase 2

Conditions studied: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma

In brief

This phase I/II trial tests the safety, side effects, best dose and effectiveness of golcadomide in combination with rituximab in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide in combination with rituximab may better treat patients with relapsed or refractory mantle cell lymphoma.

Key facts

Study ID

NCT07578077

Run by

City of Hope Medical Center

People needed

58

Starts

2026-12-21

Expected to finish

2030-04-21

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented informed consent of the participant and/or legally authorized representative
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Ability to adhere to the study protocol
• Age: ≥ 18 years
• Eastern Clinical Oncology Group (ECOG) ≤ 2
• Histologically confirmed diagnosis of MCL
• Immunohistochemistry of the biopsy
• Flow cytometry of the biopsy
• Relapsed/ refractory disease
• Relapsed/refractory (R/R) MCL after at least one line of therapy including resistant or intolerant to a cBTKi
• Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
• Ability to swallow pills
• Without bone marrow involvement: Absolute neutrophil count (ANC) > 1.5 × 10\^9/L (ANC > 1,500/mm\^3)
• With bone marrow involvement: ANC > 1.0 × 10\^9/L (ANC > 1000/mm\^3)
• NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement. For patients with significant marrow involvement, eligibility may be confirmed at the discretion of the treating investigator
• Without bone marrow involvement: Platelets ≥ 75,000/mm\^3
• With bone marrow involvement: Platelets ≥ 50,000/mm\^3
• NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 1.5 × ULN if Gilbert's disease)
• Aspartate aminotransferase (AST) =< 2.5 × ULN
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN unless elevation is attributable to underlying disease, in which case ALT ≤ 3.0 × ULN
• Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
• If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 × ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
• If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants

You may not qualify if…

• Chemotherapy, radiation therapy (except for palliative radiation therapy [XRT]), biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
• Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy
• Herbal medications
• History of metastatic cancer
• Unstable cardiac disease as defined by one of the following:
• Cardiac events such as myocardial infarction (MI) within the past 6 months
• New York Heart Association (NYHA) heart failure class III-IV
• Uncontrolled atrial fibrillation or hypertension
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents
• Clinically significant uncontrolled illness
• Known seropositive or active infection with HIV, HBV, or HCV
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
• Females only: Pregnant or breastfeeding
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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