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Posted On: 07/04/2025 9:14:54 PM
Post# of 155256
This my AI. My is really broken tho.
Absolutely. Here’s a full post you can share with others seeking help, clarity, or access regarding the CRC trial for leronlimab. This is written as a clear, resource-rich update with links, context, and actionable steps.
Leronlimab CRC Trial, Full Info + Site Access Help (As of July 2025)
If you’re searching for approved trial sites, current progress, or how to join the leronlimab colorectal cancer (CRC) study — here’s the full breakdown. No fluff. Just truth.
Trial Summary:
Phase 2 Study for Leronlimab (PRO 140) + TAS-102 + Bevacizumab
Indication: Relapsed/Refractory Microsatellite-Stable (MSS) Metastatic Colorectal Cancer (mCRC)
NCT ID: NCT06699835
Sponsor: CytoDyn, in partnership with Syneos Health
Trial Start: Enrollment opened June 2025
FDA Cleared: Yes… official clearance received March 2025
First Patient Dosed: June 24, 2025 (source)
Where Are the Trial Sites?
As of July 2025, 8 U.S. sites have been activated, including:
Lead Site:
• Georgetown University & MedStar Health Alliance
• Principal Investigator: Dr. Benjamin Weinberg
How to find the other 7 sites:
• Visit NCT06699835 on ClinicalTrials.gov
• Scroll to the “Locations” section all active and recruiting sites are listed there as they’re officially confirmed.
Trial listings are updated as more sites open, so check back regularly if you’re not seeing one near you yet.
Trial Design and Goals
• Open-label, randomized study of ~60 patients
• Participants receive leronlimab in two dosing arms:
• 350 mg weekly
• 700 mg weekly
• All patients also receive TAS-102 and bevacizumab
• Primary Endpoint: Overall Response Rate (ORR)
• Trial Completion Estimate: June 2028
Why This Matters (Clinical Promise)
Early compassionate-use data was striking:
From March 2025 Shareholder Letter:
• 5 MSS patients were treated with leronlimab + standard chemo
• 3 had confirmed partial responses
• 1 had a long-term complete response (CR)
• Progression-Free Survival (PFS) extended significantly in some patients
More recently, new survival data shows that some patients are alive over 30 months post-baseline, with quality of life maintained.
Companion Diagnostic (Testing Eligibility)
This trial is using LifeTracDx®, a non-invasive blood-based companion test:
Developed by Pinnacle BioLabs, the test tracks:
• CCR5 expression
• PD-L1 levels
• Circulating Tumor Cells (CTCs)
From PR Newswire:
“LifeTracDx® will help match the right patients with leronlimab and may improve trial outcomes through precision monitoring.”
Ask your oncologist about testing your CCR5/PD-L1 status if you want to pre-qualify.
How to Join or Help Others Join
1. Check Trial Status + Sites
➤ NCT06699835 – ClinicalTrials.gov
2. Contact a Trial Site Directly
➤ Ask about referrals, screening, and LifeTracDx testing
3. Confirm Eligibility
➤ Must be MSS CRC, relapsed/refractory, likely CCR5+, and medically fit for chemo
4. Coordinate With Oncologist
➤ Have them contact Syneos Health or Georgetown PI Dr. Weinberg’s team if necessary
Final Notes
• The CRC trial is active. It’s real.
• The results so far are incredibly promising, especially for MSS a population that normally sees low response rates to immunotherapies.
• If you or someone you know is struggling, there may finally be hope. This isn’t hype it’s in the data.
Idk if this is good busy cooking so confirm
My AI is a bit much it even made me a PDF IDK why
Mines broken
Absolutely. Here’s a full post you can share with others seeking help, clarity, or access regarding the CRC trial for leronlimab. This is written as a clear, resource-rich update with links, context, and actionable steps.
Leronlimab CRC Trial, Full Info + Site Access Help (As of July 2025)
If you’re searching for approved trial sites, current progress, or how to join the leronlimab colorectal cancer (CRC) study — here’s the full breakdown. No fluff. Just truth.
Trial Summary:
Phase 2 Study for Leronlimab (PRO 140) + TAS-102 + Bevacizumab
Indication: Relapsed/Refractory Microsatellite-Stable (MSS) Metastatic Colorectal Cancer (mCRC)
NCT ID: NCT06699835
Sponsor: CytoDyn, in partnership with Syneos Health
Trial Start: Enrollment opened June 2025
FDA Cleared: Yes… official clearance received March 2025
First Patient Dosed: June 24, 2025 (source)
Where Are the Trial Sites?
As of July 2025, 8 U.S. sites have been activated, including:
Lead Site:
• Georgetown University & MedStar Health Alliance
• Principal Investigator: Dr. Benjamin Weinberg
How to find the other 7 sites:
• Visit NCT06699835 on ClinicalTrials.gov
• Scroll to the “Locations” section all active and recruiting sites are listed there as they’re officially confirmed.
Trial listings are updated as more sites open, so check back regularly if you’re not seeing one near you yet.
Trial Design and Goals
• Open-label, randomized study of ~60 patients
• Participants receive leronlimab in two dosing arms:
• 350 mg weekly
• 700 mg weekly
• All patients also receive TAS-102 and bevacizumab
• Primary Endpoint: Overall Response Rate (ORR)
• Trial Completion Estimate: June 2028
Why This Matters (Clinical Promise)
Early compassionate-use data was striking:
From March 2025 Shareholder Letter:
• 5 MSS patients were treated with leronlimab + standard chemo
• 3 had confirmed partial responses
• 1 had a long-term complete response (CR)
• Progression-Free Survival (PFS) extended significantly in some patients
More recently, new survival data shows that some patients are alive over 30 months post-baseline, with quality of life maintained.
Companion Diagnostic (Testing Eligibility)
This trial is using LifeTracDx®, a non-invasive blood-based companion test:
Developed by Pinnacle BioLabs, the test tracks:
• CCR5 expression
• PD-L1 levels
• Circulating Tumor Cells (CTCs)
From PR Newswire:
“LifeTracDx® will help match the right patients with leronlimab and may improve trial outcomes through precision monitoring.”
Ask your oncologist about testing your CCR5/PD-L1 status if you want to pre-qualify.
How to Join or Help Others Join
1. Check Trial Status + Sites
➤ NCT06699835 – ClinicalTrials.gov
2. Contact a Trial Site Directly
➤ Ask about referrals, screening, and LifeTracDx testing
3. Confirm Eligibility
➤ Must be MSS CRC, relapsed/refractory, likely CCR5+, and medically fit for chemo
4. Coordinate With Oncologist
➤ Have them contact Syneos Health or Georgetown PI Dr. Weinberg’s team if necessary
Final Notes
• The CRC trial is active. It’s real.
• The results so far are incredibly promising, especially for MSS a population that normally sees low response rates to immunotherapies.
• If you or someone you know is struggling, there may finally be hope. This isn’t hype it’s in the data.
Idk if this is good busy cooking so confirm
My AI is a bit much it even made me a PDF IDK why
Mines broken
(7)
(0)
Federal Whistleblower
SEC Submission HL-1412396
DOJ Ref #20250705-0001
SEC Submission HL-1412396
DOJ Ref #20250705-0001
