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

NCT07578077 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 25448NCI-2026-02921P30CA033572
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

  During cycle 1 (Cycle length = 28 days)

• Maximum tolerated dose (MTD) of golcadomide

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

  Up to 3 years

• MTD of golcadomide in combination with rituximab

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

  Up to 3 years

• 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.

  Up to 3 years

• 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.

  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)

• Incidence of adverse events

  Up to 3 years

• Duration of response (DOR) of the combination of golcadomide and rituximab

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

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

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

• Complete response (CR) of the combination of golcadomide and rituximab

  Up to 3 years

Study Arms (2)

Phase I (Golcadomide)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Golcadomide; Procedure: Positron Emission Tomography

Phase II (Golcadomide, rituximab)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Golcadomide; Procedure: Positron Emission Tomography; Biological: Rituximab

Interventions

Biopsy Procedure PROCEDURE

Undergo tissue biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Golcadomide DRUG

Given PO

Also known as: BMS 986369, BMS-986369, BMS986369, CC -99282, CC 99282, CC99282, CelMod CC-99282, Cereblon E3 Ubiquitin Ligase Modulating Agent CC-99282, Cereblon E3 Ubiquitin Ligase Modulating Drug CC-99282, Cereblon Modulator CC-99282

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Phase I (Golcadomide); Phase II (Golcadomide, rituximab)

Rituximab BIOLOGICAL

Given IV

Also known as: ABP 798, ABP-798, ABP798, BI 695500, BI-695500, BI695500, Blitzima, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT P10, CT-P10, CTP10, GP 2013, GP-2013, GP2013, IDEC 102, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, IDEC102, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF 05280586, PF-05280586, PF05280586, Riabni, Ritemvia, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar GP2013, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, Rituximab-abbs, Rituximab-arrx, Rituximab-blit, Rituximab-pvvr, Rituximab-rite, Rituximab-rixa, Rituximab-rixi, Rixathon, Riximyo, RTXM 83, RTXM-83, RTXM83, Ruxience, Truxima

Phase II (Golcadomide, rituximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy; Rituximab; CT-P10

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tycel J Phillips

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): December 21, 2026
• Primary Completion (Estimated): April 21, 2030
• Study Completion (Estimated): April 21, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)