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Golcadomide with Rituximab for Relapsed or Refractory Mantle Cell Lymphoma

This study is testing a combination of two drugs, golcadomide and rituximab, for people with mantle cell lymphoma that has returned (relapsed) or isn't responding to other treatments (refractory). Golcadomide may help stop cancer cells from growing, and rituximab is a monoclonal antibody that helps your immune system kill cancer cells. Researchers want to find the safest and most effective dose of golcadomide, both alone and with rituximab. They will also look at how well this combination works. You may be able to join if you are at least 18 years old and meet other health criteria. The study is currently recruiting 58 participants, but its status is unclear.

Study design
This is a Phase I/II interventional study with a planned enrollment of 58 participants. It is designed to evaluate the safety, side effects, and effectiveness of golcadomide, alone and in combination with rituximab.
What's involved
You would undergo procedures like tissue biopsies, blood sample collection, bone marrow biopsies, and PET/CT scans. You would take golcadomide by mouth once daily on days 1-14 of each 28-day cycle, for up to 24 cycles.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose of golcadomide will be measured for up to 3 years. The maximum tolerated dose of golcadomide in combination with rituximab will also be measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07578077

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~58 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionBone Marrow BiopsyComputed TomographyGolcadomidePositron Emission Tomography

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLT)
Measured over During cycle 1 (Cycle length = 28 days)
+4 more outcomes measured

Conditions

Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma

Explore related trials

Mantle Cell Lymphoma

NCT07578077

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tycel J Phillips · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Tycel J. Phillips
[email protected]
626-256-4673 · ext. 82405
Email the study team

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Eligibility criteria

Inclusion

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
Seronegative for HIV
Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative)
Meets other institutional and federal requirements for infectious disease titer requirements
Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Woman of childbearing potential must have a negative pregnancy test using a highly sensitive assay (minimum sensitivity 25 IU/L) performed within 10 to 14 days and again within 24 hours prior to receiving the first dose of golcadomide/BMS-986369
Agreement by females of childbearing potential to use two effective methods of contraception simultaneously without interruption, for at least 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions, and for at least 28 days after the last dose of golcadomide/BMS-986369. The two methods of contraception must include one highly effective method and one additional effective method. Compliance will be documented using the Clinical Trial Pregnancy Risk Awareness Checklist, which must be completed and provided to participants at screening and prior to dispensing of study drug. An individual of childbearing potential (IOCBP) is defined as:
A person who has achieved menarche, has not undergone a documented hysterectomy or bilateral oophorectomy, and has not been naturally postmenopausal for at least 12 consecutive months. Amenorrhea resulting from medical interventions (such as cancer therapy), rather than natural menopause, does not exclude childbearing potential.
Achievement of menarche (onset of menstruation).
No history of surgical sterilization:
No documented hysterectomy
No documented bilateral oophorectomy
Not naturally postmenopausal:
Defined as absence of menses for ≥ 12 consecutive months due to natural causes (not due to medical interventions such as chemotherapy, hormonal therapy, or radiotherapy)
Amenorrhea due to medical causes (e.g., cancer therapy, hormonal treatment) does not qualify as natural menopause and does not exclude childbearing potential

Exclusion

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)

What this trial measures

  • Incidence of dose limiting toxicities (DLT)During cycle 1 (Cycle length = 28 days)

    The adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v 5.0). Toxicity will be summarized by type, severity, and attribution. DLT will be individually described.

  • Maximum tolerated dose (MTD) of golcadomideUp to 3 years

    If single agent is tolerable, we will subsequently explore golcadomide in combination with rituximab.

  • MTD of golcadomide in combination with rituximabUp to 3 years

    Patients would remain on therapy until unacceptable toxicity, treating physician discretion or PD.

  • Overall response rate (ORR)Up to 3 years

    Defined as achieving a best response of either complete metabolic response (CMR) or partial metabolic response (PMR) in a response-evaluable participant after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated by binary proportions, along with the 95% exact binomial confidence intervals.

  • Progression free survival (PFS)From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 3 years

    PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.