Clinical Trials Logo

Clinical Trial 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 CLL/SLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituximab for patients aged <65 years without del17p/TP53 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 for/unresponsive 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 relapsed/refractory 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04704323
Study type Observational
Source Catapult Therapeutics
Contact Dominik Höchli, MD
Phone +31 611846572
Email d.hochli@catapult-therapeutics.com
Status Recruiting
Phase
Start date September 10, 2021
Completion date April 2025

See also
  Status Clinical Trial Phase
Completed NCT01072240 - An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia N/A
Completed NCT00754650 - A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia Phase 2
Active, not recruiting NCT02500407 - A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) Phase 1/Phase 2
Active, not recruiting NCT01414205 - A Study Comparing RO5072759 (GA101) 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GAGE) Phase 2
Completed NCT01224093 - An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC) N/A
Completed NCT01395615 - An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia N/A
Completed NCT00532129 - A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Chronic Lymphocytic Leukemia. Phase 2
Completed NCT02013817 - CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy Phase 2
Completed NCT01685892 - A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia Phase 1
Completed NCT00738374 - A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia. Phase 2
Completed NCT00241358 - Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT01056510 - A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe) Phase 4
Completed NCT01300247 - A Study of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GALTON) Phase 1
Terminated NCT01271010 - A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status Phase 4
Completed NCT00718549 - A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL) Phase 3
Completed NCT01263704 - A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia Phase 2
Completed NCT00431873 - A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia Phase 2
Completed NCT01178086 - A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Terminated NCT02292225 - Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY) Phase 1
Completed NCT02533401 - A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL) Phase 2