CAP-100 for Relapsed/Refractory Chronic Lymphocytic Leukemia
This study is testing a drug called CAP-100 for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or hasn't responded to at least two previous treatments. CAP-100 is a human-made antibody that targets a specific protein called CCR7. Researchers want to see how safe CAP-100 is and if it causes any side effects, especially at different doses. They will also look for early signs that the drug is helping patients. You may be able to join if you are at least 18 years old, have CLL or SLL that has relapsed or is refractory, and meet other health criteria. The study plans to enroll 18 participants, but the current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 18 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects for 28 days and look for clinical benefit for 3 cycles (84 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
At a glance
Conditions
Where it's being run
4 sites across 3 statesWho to contact
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What this trial measures
- Incidence of treatment emergent adverse effects at increasing doses of CAP-100 (safety and tolerability)28 Days
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs. The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
- Incidence of treatment emergent adverse effects of CAP-100 at RP2D in an expanded cohort (safety and tolerability)28 Days
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs. The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
- Preliminary clinical benefit of CAP-100 monotherapy at RP2D3 Cycles (84 Days)
Overall response rate (ORR) after 3 cycles of CAP-100 treatment according to iwCLL criteria