Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04704323
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2020-12-21
Brief Title:
CAP-100 for Subjects With RelapsedRefractory Chronic Lymphocytic Leukemia
Sponsor:
Catapult Therapeutics
Organization:
Catapult Therapeutics
Study Overview
Official Title:
An Open Label Phase Iab Dose Escalation Followed by Dose Expansion Safety and Tolerability Trial of CAP-100 a Humanized C-C-chemokine Receptor 7 Antibody Administered as Monotherapy in Subjects With rr Chronic Lymphocytic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases Presently first-line therapies for CLLSLL include targeted therapies eg ibrutinib acalabrutinib or combined immuno-chemotherapy regimens eg fludarabine cyclophosphamide and rituximab for patients aged 65 years without del17pTP53 mutations or bendamustine and rituximab for patients 65 years who have additional comorbidities
Despite the gradual introduction of targeted therapies new treatment strategies efficacious for patients ineligible forunresponsive to these therapies are still required These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges Emerging treatment options include new compounds aimed for both untreated and relapsedrefractory CLL and combination therapies of existing compounds that extend single-agent efficacy in specific high-risk patient populations
CAP-100 is expected to prevent the migration of leukemia cells to and their survival in lymphoid niches as well as to eliminate CCR7-positive leukemia cells via ADCC resulting in measurable clinical responses
The present trial is the first-in-human trial of CAP-100 and is divided into two phases The aim of the Phase Ia dose escalation is to define the Recommended Phase 2 Dose RP2D versus the Maximum Tolerated Dose MTD of CAP-100 in subjects with CLL
Phase Ib of the trial expansion phase will evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D response rate lymph node size reduction assessment of minimal residual disease MRD to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL
Despite the gradual introduction of targeted therapies new treatment strategies efficacious for patients ineligible forunresponsive to these therapies are still required These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges Emerging treatment options include new compounds aimed for both untreated and relapsedrefractory CLL and combination therapies of existing compounds that extend single-agent efficacy in specific high-risk patient populations
CAP-100 is expected to prevent the migration of leukemia cells to and their survival in lymphoid niches as well as to eliminate CCR7-positive leukemia cells via ADCC resulting in measurable clinical responses
The present trial is the first-in-human trial of CAP-100 and is divided into two phases The aim of the Phase Ia dose escalation is to define the Recommended Phase 2 Dose RP2D versus the Maximum Tolerated Dose MTD of CAP-100 in subjects with CLL
Phase Ib of the trial expansion phase will evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D response rate lymph node size reduction assessment of minimal residual disease MRD to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None