CLN-619 for Multiple Myeloma

Not currently recruiting at 9 trial locations

Overseen By Timna Serino

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cullinan Therapeutics Inc.

Must not be taking: Immunosuppressants, Corticosteroids, Antivirals, others

Disqualifiers: Autoimmune disease, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CLN-619 for individuals with multiple myeloma that has returned or not responded to other treatments. The trial aims to determine if CLN-619 is safe and effective for this condition. Participants will receive increasing doses of CLN-619 to identify the optimal dose for future studies. Suitable candidates have multiple myeloma that hasn't improved with other treatments and have symptoms measurable by their doctors. As a Phase 1 trial, participants will be among the first to receive CLN-619, aiding researchers in understanding how the treatment works in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like immunosuppressive drugs or treatments for infections close to the start of the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that CLN-619 is likely to be safe for humans?

Research has shown that CLN-619, a new treatment for multiple myeloma, was safe in earlier studies. Patients who received only CLN-619 generally tolerated it well, and serious side effects rarely occurred.

The FDA approved further testing of CLN-619, indicating that the previous safety results were sufficient to proceed with more detailed studies. Although it's still early, current evidence suggests that CLN-619 could be a safe option for people with relapsed and refractory multiple myeloma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often involve combinations of chemotherapy, immunotherapy, and targeted therapies like proteasome inhibitors, CLN-619 works differently. Researchers are excited about CLN-619 because it targets a specific pathway in the cancer cells that has not been fully explored by current treatments. This novel mechanism of action could potentially offer a new way to combat the disease, especially for patients who have relapsed or are resistant to existing therapies. By focusing on this unique target, CLN-619 might provide new hope for improved outcomes in multiple myeloma treatment.

What evidence suggests that CLN-619 might be an effective treatment for multiple myeloma?

Research has shown that CLN-619 helps the immune system recognize and attack cancer cells by restoring certain proteins, called MICA/B, on tumor cells. These proteins enable the immune system to find and destroy cancer cells more easily. Early studies suggest that CLN-619 can improve survival rates in patients with some types of cancer by enhancing immune system effectiveness. The treatment maintains the presence of MICA/B proteins on the surface of tumor cells, aiding immune cells in identifying and eliminating them. This method has shown promise in treating relapsed and refractory multiple myeloma, a type of blood cancer. Participants in this trial will receive CLN-619 in a dose-escalation study to determine the optimal dose for treating relapsed and refractory multiple myeloma. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed and refractory multiple myeloma. Participants must have measurable disease, be in fair health (ECOG performance status of 0-2), and have normal liver, kidney, and blood function. They should not have had radiotherapy within the last two weeks and must expect to live at least another 12 weeks.

Inclusion Criteria

My doctor expects me to live 12 weeks or more.

My multiple myeloma has come back and is not responding to treatment.

My cancer can be measured by tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Cohorts of patients with relapsed and refractory multiple myeloma will be treated at ascending doses of CLN-619 using a standard 3+3 dose escalation design

3 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• CLN-619

Trial Overview The study tests CLN-619, an anti-MICA/MICB antibody, for safety and effectiveness in treating multiple myeloma that has come back or hasn't responded to treatment. It's a Phase 1b trial where everyone gets the same experimental therapy.

How Is the Trial Designed?

Group I: Part 1 Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06381141

A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients ... 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 ...

2. targetedonc.com targetedonc.com/view/fda-clears-ind-of-cln-619-in-r-r-multiple-myeloma

FDA Clears IND of CLN-619 in R/R Multiple Myeloma As we shared at [Society of Immunotherapy for Cancer] 2023, CLN-619 restores MICA/B expression on tumor cells, enabling immune recognition.”.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06737

A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients ... A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma. Trial Status: closed to accrual. Open all sections

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020772/

CLN-619, a MICA/B monoclonal antibody that promotes ... Kaplan-Meier survival analysis demonstrated that CLN-619 treatment resulted in a statistically significant survival benefit as compared with ...

5. cullinantherapeutics.com cullinantherapeutics.com/wp-content/uploads/2023/01/mica-final-aacr-poster.pdf

CLN-619, a clinical-stage MICA/MICB-specific IgG1 ... CLN-619 prevents the proteolytic release of MICA/MICB thereby exposing tumor cells for immune destruction through both NKG2D-mediated and antibody- dependent ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06381141

NCT06381141 | A Study of CLN-619 (Anti-MICA/MICB ... 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 ...

7. massbioportalimages.blob.core.windows.net massbioportalimages.blob.core.windows.net/massbioportalimages/438e995e4c19ef119f8a6045bd080fcb/Cullinan%20Therapeutics%20to%20Present%20Data%20for%20CLN-619,%20a%20Novel%20Anti-MICA_B%20Antibody,%20at%20ASCO%202024.pdf

Cullinan Therapeutics to Present First Data for CLN-619 ... - NET “Additionally, longer-term follow-up for patients treated with CLN-619 monotherapy shows favorable safety and durable clinical benefit with ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20581381

A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients ... The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and ...