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Trial Title:
A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma
NCT ID:
NCT06381141
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Relapsed and Refractory Multiple Myeloma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CLN-619
Description:
Anti-MICA/MICB monoclonal antibody
Arm group label:
Part 1 Dose Escalation
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥ 18 years at the time of signing the ICF.
2. Willing and able to give written informed consent and adhere to protocol
requirements.
3. Patient has a history of multiple myeloma with relapsed and refractory disease as
defined by the protocol.
4. Patients must have measurable disease (as determined by the local laboratory) as
defined by the protocol.
5. Performance status of 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG)
performance scale.
6. Estimated life expectancy of 12 weeks or longer.
7. Prior palliative radiotherapy must have been completed at least 14 days prior to
dosing on Cycle 1 Day 1.
8. 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.
9. Have adequate liver and kidney function and hematological parameters within a normal
range as defined by the protocol.
Exclusion Criteria:
1. Patient has symptomatic central nervous system involvement of MM.
2. Patient has nonsecretory MM, plasma cell leukemia, Waldenstrom's macroglobulinemia,
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein,
and skin changes), or amyloidosis.
3. Patient had a prior autologous stem cell transplant ≤ 3 months prior to first dose
of study drug on Cycle 1 Day 1.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Patient has active peripheral neuropathy or neuropathic pain Grade 2 or higher, as
defined by the NCI-CTCAE v5.0.
10. Diagnosed with HIV, Hepatitis B, or Hepatitis C infection.
11. 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.
12. 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.
13. 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.
14. 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.
15. Certain treatment with investigational agents and other anti-neoplastic therapy as
defined by the protocol
16. 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.
17. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Knight
Phone:
214-648-4118
Email:
Jennifer.Knight@utsouthwestern.edu
Investigator:
Last name:
Larry D Anderson, MD, PhD, FACP
Email:
Principal Investigator
Start date:
September 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Cullinan Therapeutics Inc.
Agency class:
Industry
Source:
Cullinan Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06381141
