Recruiting
Phase 1
Phase 2

Golcadomide & Rituximab

Sponsor:

City of Hope Medical Center

Code:

NCT07578077

Conditions

Recurrent Mantle Cell Lymphoma

Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Bone Marrow Biopsy

Computed Tomography

Golcadomide

Study Details

Brief summary:

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.

Conditions

Recurrent Mantle Cell Lymphoma

Refractory Mantle Cell Lymphoma

Study ID

NCT07578077

Start date

Dec 21, 2026

Status verified date

Oct, 2026

Completion date

Apr 21, 2030

Anticipated

Primary completion date

Apr 21, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

58 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I (Golcadomide)

Patients receive golcadomide PO QD on days 1-14 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.

experimental: Phase II (Golcadomide, rituximab)

Patients receive golcadomide PO QD on days 1-14 of each cycle. Patients also receive rituximab IV on days 1, 8, 15 and 22 of cycle 1 and then day 1 of even cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.

Interventions

Biopsy Procedure

Undergo tissue biopsy

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Biopsy

Undergo bone marrow biopsy

Computed Tomography

Undergo PET/CT

Golcadomide

Given PO

Positron Emission Tomography

Undergo PET/CT

Rituximab

Given IV

Primary outcome measure

  • Incidence of dose limiting toxicities (DLT) [ Time Frame: During cycle 1 (Cycle length = 28 days) ]
  • Maximum tolerated dose (MTD) of golcadomide [ Time Frame: Up to 3 years ]
  • MTD of golcadomide in combination with rituximab [ Time Frame: Up to 3 years ]
  • Overall response rate (ORR) [ Time Frame: Up to 3 years ]
  • Progression free survival (PFS) [ Time Frame: 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 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Tycel J. Phillips

626-256-4673tphillips@coh.org

Principal Investigator:

Tycel J. Phillips

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.