Multiple MyelomaPhase 1NCT06381141
A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing CLN-619 in people with Multiple Myeloma, run by Cullinan Therapeutics Inc. at 8 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CLN-619
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Sep 2024to Mar 2027
- Phase
- Phase 1
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- Female of child-bearing potential (FOCBP) who is pregnant or breast-feeding, plans to become pregnant within 120 days of last study drug administration or declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days after the last dose of study drug administration.
- Male patients who plans to father a child or donate sperm within 120 days or 5 half-lives of CLN-619, whichever comes later, of last study drug administration, or who has a partner who is a FOCBP, and declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days or 5 half-lives of CLN-619, whichever comes later, after the last dose of study drug administration.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Mayo Clinic
Jacksonville, Florida, 32224
Mt. Sinai
New York, New York, 10029
Memorial Sloan Kettering (MSK)
New York, New York, 10065
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Levine Cancer Institute
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
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
- Being tested
- CLN-619
- Keywords
- Relapsed and Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-619Drug
Anti-MICA/MICB monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CLN-619 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of AEs and SAEs using MedDRA
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 2 years
Overall Survival (OS)
Time from the date of first dose to date of death due to any cause.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start3 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381141
- Sponsor's protocol ID
- CLN-619-002
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06381141
- Acronym / sponsor ID
- CLN-619-002
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed and Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cullinan Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: CLN-619Cohorts of patients with R/R MM will be treated at ascending doses of CLN-619 using a standard 3+3 dose escalation design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLN-619Anti-MICA/MICB monoclonal antibody | Drug | Part 1 Dose Escalation |
Primary outcome
Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: baseline through 3-week treatment period
Incidence of AEs and SAEs using MedDRA
Changes in Eastern Cooperative Oncology Group (ECOG) performance
Time frame: Up to 2 years
ECOG Scores are a functional scale ranging from 0 (Fully active, able to carry out all pre-disease activities without restrictions) to 5 (Death)
Incidence of Dose-Limiting toxicity (DLTs)
Time frame: up to 2 years
Maximum Tolerated Dose (MTD) is reached if 2 or more patients experience a DLT at a dose level
Best Overall Response (BOR) per patient
Time frame: up to 2 years
The best response defined by the International Myeloma Working Group (IMWG) criteria recorded throughout the study including unscheduled assessments
Overall Response Rate (ORR)
Time frame: up to 2 years
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
Duration of Response (DoR)
Time frame: up to 2 years
The time from the earliest date of documented response to the first documented disease progression or death, whichever occurs first.
Clinical Benefit Rate (CBR)
Time frame: up to 2 years
The proportion of patients with a best overall response of CR, PR and stable disease (SD), according to IMWG response criteria
Progression Free Survival (PFS)
Time frame: up to 2 years
The time from date of first dose until the earliest date of disease progression, or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: up to 2 years
Time from the date of first dose to date of death due to any cause.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLN-619 in people with Multiple Myeloma, run by Cullinan Therapeutics Inc. at 8 sites 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 9 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: baseline through 3-week treatment period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.