A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma

NCT06381141 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CLN-619-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief Summary

A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma

Conditions

Multiple Myeloma

Keywords

Relapsed and Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (9)

• Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Incidence of AEs and SAEs using MedDRA

  baseline through 3-week treatment period

• Changes in Eastern Cooperative Oncology Group (ECOG) performance

  ECOG Scores are a functional scale ranging from 0 (Fully active, able to carry out all pre-disease activities without restrictions) to 5 (Death)

  Up to 2 years

• Incidence of Dose-Limiting toxicity (DLTs)

  Maximum Tolerated Dose (MTD) is reached if 2 or more patients experience a DLT at a dose level

  up to 2 years

• Best Overall Response (BOR) per patient

  The best response defined by the International Myeloma Working Group (IMWG) criteria recorded throughout the study including unscheduled assessments

  up to 2 years

• Overall Response Rate (ORR)

  The proportion of patients who achieve a partial response or better (e.g., Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) or stringent Complete Response (sCR), according to IMWG response criteria

  up to 2 years

• Duration of Response (DoR)

  The time from the earliest date of documented response to the first documented disease progression or death, whichever occurs first.

  up to 2 years

• Clinical Benefit Rate (CBR)

  The proportion of patients with a best overall response of CR, PR and stable disease (SD), according to IMWG response criteria

  up to 2 years

• Progression Free Survival (PFS)

  The time from date of first dose until the earliest date of disease progression, or death from any cause, whichever occurs first.

  up to 2 years

• Overall Survival (OS)

  Time from the date of first dose to date of death due to any cause.

  up to 2 years

Study Arms (1)

Part 1 Dose Escalation

EXPERIMENTAL

Cohorts of patients with R/R MM will be treated at ascending doses of CLN-619 using a standard 3+3 dose escalation design.

Drug: CLN-619

Interventions

CLN-619 DRUG

Anti-MICA/MICB monoclonal antibody

Part 1 Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 18 years at the time of signing the ICF.
• Willing and able to give written informed consent and adhere to protocol requirements.
• Patient has a history of multiple myeloma with relapsed and refractory disease as defined by the protocol.
• Patients must have measurable disease (as determined by the local laboratory) as defined by the protocol.
• Performance status of 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• Estimated life expectancy of 12 weeks or longer.
• Prior palliative radiotherapy must have been completed at least 14 days prior to dosing on Cycle 1 Day 1.
• Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0, except for alopecia. Patients with chronic but stable Grade 2 toxicities may be allowed to enroll after an agreement between the Investigator and Sponsor.
• Have adequate liver and kidney function and hematological parameters within a normal range as defined by the protocol.

You may not qualify if:

• Patient has symptomatic central nervous system involvement of MM.
• Patient has nonsecretory MM, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
• Patient had a prior autologous stem cell transplant ≤ 3 months prior to first dose of study drug on Cycle 1 Day 1.
• Patient had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior first dose of study drug on Cycle 1 Day 1 or is on systemic immunosuppression for graft-versus-host disease.
• Patients with concomitant second malignancies (Except adequately treated non-melanomatous skin cancers, ductal carcinoma in situ, superficial bladder cancer, prostate cancer, Grade 1 stage 1A/1B endometrioid endometrial cancer or cervical cancer in situ) are excluded unless in complete remission three years prior to study entry, and no additional therapy is required or anticipated to be required during study participation.
• Patients with any active autoimmune disease or a history of known or suspected autoimmune disease, or history of a syndrome that requires systemic corticosteroids treatment or immunosuppressive medications, except for patients with vitiligo, resolved childhood asthma/atopy or autoimmune thyroid disorders on stable thyroid hormone supplementation.
• A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
• Treatment with systemic antiviral, antibacterial or antifungal agents for acute infection within ≤ 7 days of first dose of study drug on Cycle 1 Day 1.
• Patient has active peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI-CTCAE v5.0.
• Diagnosed with HIV, Hepatitis B, or Hepatitis C infection.
• Treatment with non-oncology vaccines for the control of infectious diseases (i.e., HPV vaccine) within 28 days of first dose of study drug on Cycle 1 Day 1.
• Active SARS-CoV-2 infection based on positive SARS-CoV-2 test within 4 weeks prior to enrollment or patients with suspected active infection based on clinical features or pending results.
• Has received immunosuppressive medications including but not limited to CellCept, methotrexate, infliximab, anakinra, tocilizumab, cyclosporine, or corticosteroids (≥ 10 mg/day of prednisone or equivalent), within 28 days of first dose of study drug on Cycle 1 Day 1.
• Patient has history of drug-related anaphylactic reactions to any components of CLN-619. History of Grade 4 anaphylactic reaction to any monoclonal antibody therapy.
• Certain treatment with investigational agents and other anti-neoplastic therapy as defined by the protocol

Sponsors & Collaborators

• Cullinan Therapeutics Inc.: lead

Study Sites (8)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering (MSK)

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Levine Cancer Institute

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 24, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (8)