RecruitingNon Hodgkin LymphomaRichter TransformationMultiple Myeloma
Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.
Eligible age
13+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.
Sponsor: Newave Pharmaceutical Inc
You may qualify if…
- ✓ 1. Male or female subjects, ≥ 18 years of age at the time of Screening with the following exception as outlined below:
- ✓ For T cell and B cell ALL subjects with age between 13 - 18 years, their body weight shall be ≥ 40 kg.
- ✓ 2. Eligible subject must have an advanced hematologic malignancy including:
- ✓ Group 1:
- ✓ Group 1a
- ✓ Relapsed or refractory low risk tumor lysis CLL/SLL subjects (ALC \< 25 x 109 cells/L and all lymph nodes \< 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.
- ✓ For CLL/SLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days as these subjects, progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).
- ✓ Group 1b
You may not qualify if…
- ✕ A subject will not be eligible for study participation if he/she meets any of the following criteria.
- ✕ 1. Subjects who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-118, or subjects on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and/or up to 20 mg/day prednisone or equivalent systemic steroids for ongoing GVHD is permitted.
- ✕ 2. Subject has a history of other malignancies within past 12 months that are active and could result in competing risks. These cases shall be discussed with the Medical Monitor with the exception below.
- ✕ Subject with breast cancer or prostate cancer on endocrine therapy with stable disease;
- ✕ Continuation of maintenance therapy in patients with adequately treated malignancy
- ✕ Adequately treated in situ carcinoma of the cervix uteri;
- ✕ Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- ✕ Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Where it's recruiting
Illinois
Chicago
Massachusetts
Boston
North Carolina
Chapel Hill
Ohio
Cincinnati · Columbus
Texas
Houston
Utah
Salt Lake City
Source: ClinicalTrials.gov · NCT04771572 · last updated 2026-05-05