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OncoMatch/Clinical Trials/NCT04771572

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.

Is NCT04771572 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies LP-118 for non hodgkin lymphoma.

Phase 1RecruitingNewave Pharmaceutical IncNCT04771572Data as of May 2026

Treatment: LP-118This 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.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Non-Hodgkin Lymphoma

Multiple Myeloma

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myeloproliferative Neoplasm

Chronic Lymphocytic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: BTK inhibitor — CLL/SLL

Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.

Must have received: BCR antagonist — CLL/SLL

For CLL/SLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days

Must have received: JAK2 antagonist — MF

For MF subjects who come off JAK2 antagonists, allow washout for 2 days

Must have received: proteasome inhibitor — MM

Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38

Must have received: immunomodulatory drug — MM

Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38

Must have received: anti-CD38 — MM

Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38

Must have received: tyrosine kinase inhibitor (bosutinib, dasatinib, imatinib, nilotinib, ponatinib) — ALL (B cell phenotype)

ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and/or tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed

Must have received: CD19-based target therapy (blinatumomab) — ALL (B cell phenotype)

currently ineligible/intolerant for CD19-based target therapy (e.g. Blinatumomab)

Cannot have received: autologous/allogeneic hematopoietic stem cell transplantation

Exception: allowed if >60 days since transplant and off immunosuppressive therapy for at least 4 weeks

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

Cannot have received: CAR-T cell therapy

Exception: allowed if >28 days since CAR-T and no evidence of CRS or other adverse events

There is a 28-day washout period required for subjects who have had prior CAR-T treatment if there is no evidence of cytokine release syndrome (CRS) or other adverse events related to the CAR-T treatment

Cannot have received: any anti-neoplastic therapy

Exception: allowed if >14 days or 5 half-lives (whichever is shorter) since last therapy and recovered to ≤ Grade 2 AEs (excluding neuropathy)

Any anti-neoplastic therapy including chemotherapy, hormonal therapy, radiotherapy, biologic or immunotherapy, targeted small molecule agents, etc.

Cannot have received: investigational therapy

Exception: allowed if >14 days or 5 half-lives (whichever is shorter) since last therapy

Any investigational therapy

Cannot have received: live vaccines

Live vaccines

Lab requirements

Blood counts

ANC ≥ 1 x 10^9/L (exception for heavy marrow infiltration); Platelets ≥ 50 x 10^9/L (independent of transfusion within 14 days); APPT and PT ≤ 1.5 × ULN

Kidney function

Serum creatinine ≤ ULN or CrCl ≥ 60 mL/min

Liver function

AST and ALT ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome, who may have bilirubin > 1.5 × ULN, per discussion between Investigator and Medical Monitor)

Cardiac function

Shortening fraction of ≥ 40% by 2D echocardiogram without Doppler; baseline QTcF < 480 ms; NYHA Class < 2

Adequate cardiac function defined as shortening fraction of ≥ 40% by 2D echocardiogram without Doppler. Subject must have adequate bone marrow (independent of growth factor support), coagulation, renal, and hepatic function, per laboratory reference ranges at Screening as follows...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Chicago · Chicago, Illinois
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • University of North Carolina · Chapel Hill, North Carolina
  • Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
  • University of Cincinnati · Cincinnati, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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