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Recurrent Mantle Cell LymphomaPhase 1/2NCT07578077

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

A Phase 1/2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
21 Dec 2026to 21 Apr 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Tycel J. Phillips, 626-256-4673 ext. 82405, tphillips@coh.org

    Tycel J. Phillips

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2 Study of the CELMoD Agent Golcadomide in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety and tolerance of golcadomide in mantle cell lymphoma (MCL) patients who were resistant or intolerant to covalent bruton's tyrosine kinase inhibitors (cBTKi).

II. To evaluate the safety and tolerance of golcadomide in combination with rituximab in MCL patients who were resistant or intolerant to cBTKi.

III. To estimate the efficacy of golcadomide and rituximab in MCL patients who were resistant or intolerant to cBTKi.

SECONDARY OBJECTIVES:

  1. To evaluate the complete response rate (CR) of the combination of golcadomide and rituximab.

II. To evaluate the durability of response by the duration of response (DOR) and duration of complete response (DOCR).

EXPLORATORY OBJECTIVES:

  1. Correlate clinical response with changes in baseline T cell characteristics and cytokine profiles.

II. To measure the rate of minimal residual disease undetectability in responding patients.

OUTLINE: This is a phase I, dose-escalation study of golcadomide followed by a phase II study. Patients are assigned to 1 of 2 phases.

PHASE I: Patients receive golcadomide orally (PO) once daily (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 positron emission tomography (PET)/computed tomography (CT) throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.

PHASE II: Patients receive golcadomide PO QD on days 1-14 of each cycle. Patients also receive rituximab intravenously (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.

After completion of study treatment, patients are followed up at 30 days, and then up to 3 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Golcadomide
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • GolcadomideDrug

    Also called BMS 986369, BMS-986369, BMS986369, CC -99282

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • RituximabBiological

    Also called ABP 798, ABP-798, ABP798, BI 695500

    Given IV

Study groups in NCT07578077
Study groupRoleWhat they receive
Phase I (Golcadomide)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Golcadomide; Procedure: Positron Emission Tomography
Phase II (Golcadomide, rituximab)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Golcadomide; Procedure: Positron Emission Tomography; Biological: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLT)

    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.

    Measured: During cycle 1 (Cycle length = 28 days)

  2. Maximum tolerated dose (MTD) of golcadomide

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

    Measured: Up to 3 years

  3. MTD of golcadomide in combination with rituximab

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

    Measured: Up to 3 years

  4. Overall response rate (ORR)

    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.

    Measured: Up to 3 years

  5. Progression free survival (PFS)

    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.

    Measured: 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

Secondary outcomes (4)

  1. Incidence of adverse events

    Will be graded by NCI CTCAE v 5.0. Toxicity will be summarized by type, severity, and attribution.

    Measured: Up to 3 years

  2. Duration of response (DOR) of the combination of golcadomide and rituximab

    DOR will be estimated using the product-limit method of Kaplan and Meier.

    Measured: From the first achievement of PMR or CMR to time of progressive disease (PD) or death, whichever earlier, assessed up to 3 years

  3. Duration of complete response (DOCR) of the combination of golcadomide and rituximab

    DOCR will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Time from the first achievement of CMR to time of PD or death, whichever earlier, assessed up to 3 years

  4. Complete response (CR) of the combination of golcadomide and rituximab

    CR rate will be estimated by binary proportions, along with the 95% exact binomial confidence intervals.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start21 Dec 2026 (estimated)
  3. Primary completion21 Apr 2030 (estimated)
  4. Study completion21 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07578077
Sponsor's protocol ID
25448
Other IDs
NCI-2026-02921, 25448, P30CA033572
Status last verified
Oct 2026
First submitted
5 May 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLT) (time frame: During cycle 1 (Cycle length = 28 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07578077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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