CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Catapult Therapeutics
Study ID
NCT04704323
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lymphocytic Leukemia, Chronic
  • SLL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CAP-100 — DRUG
    CAP-100 (humanized antibody against C-C-chemokine receptor 7 \[CCR\]7)

Study Details

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.

Key Dates

Start date
Sep 10, 2021
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Phase Ia - Dose escalation
    Cohorts of 3 subjects (last cohort 6 subjects) will receive intravenous \[IV\] administrations of escalating doses of CAP-100.
  • Experimental: Experimental: Phase Ib - Dose expansion
    Ten subjects will receive intravenous \[IV\] administrations of CAP-100 at the Recommended Phase 2 Dose determined in Phase Ia - Dose Escalation of this trial.

Primary Outcome Measure

Incidence of treatment emergent adverse effects at increasing doses of CAP-100 (safety and tolerability) [ Time Frame: 28 Days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Sobana Balasubramanian
[email protected]
857-215-1681
Jennifer Brown (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Terri Lucas
[email protected]
+1 919 681 6580
Danielle Brander, MD (PRINCIPAL_INVESTIGATOR)
Andrea Sitlinger, MD (SUB_INVESTIGATOR)

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