DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Description

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.

Conditions

Lymphoma, Non-Hodgkin

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Study Overview

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Study Details

Study overview

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.

A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Condition
Lymphoma, Non-Hodgkin
Intervention / Treatment

-

Contacts and Locations

New York

Research site, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female participants who have provided ICF with age ≥ 18 yrs
  • 2. ECOG performance 0-2, no deterioration in the past 2 weeks
  • 3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
  • 4. Adequate bone marrow reserve and organ system functions
  • 5. Participants willing to comply with contraceptive restrictions
  • 1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
  • 2. Prior history of allogeneic hematopoietic stem cell transplantation
  • 3. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
  • 4. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
  • 5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
  • 6. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
  • 7. Participants with infectious disease:
  • 8. Clinically significant cardiac disorders or abnormalities
  • 9. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
  • 10. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
  • 11. Women who are breast feeding
  • 12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dizal Pharmaceuticals,

Tianwei Zhang, STUDY_DIRECTOR, Dizal Pharma

Study Record Dates

2027-10-30