Irvine, CANCT05475925Now EnrollingIRB Ready

Large Granular Lymphocytic Leukemia Clinical Trial in Irvine, CA

Access cutting-edge large granular lymphocytic leukemia treatment through this phase 1/2 clinical trial at a research site in Irvine. Study-provided care at no cost to qualified participants.

Sponsored by Dren Bio

Quick Self-Assessment

See if you qualify for this Irvine location

Preparing your pre-screening questions…

Expert Care in Irvine

Access large granular lymphocytic leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related large granular lymphocytic leukemia treatment provided free

Apply for This Irvine Location

Check if you qualify for this large granular lymphocytic leukemia clinical trial in Irvine, CA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Irvine

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Irvine site if eligible
  4. 4Begin participation

About This Large Granular Lymphocytic Leukemia Study in Irvine

This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas

Sponsor: Dren Bio

Who Can Participate

Inclusion Criteria

(All Subjects):
≥18 years of age.
Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
Sufficient key organ performance and coagulation.
Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \<1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.
Male subjects must agree to use acceptable effective method(s) of contraception. Subjects with LGLL must also meet inclusion criteria 6 and 7.
Must have discontinued at least one prior line of systemic therapy.
Additional immunophenotypic and symptomatic criteria must be met. Disease-specific Inclusion Criteria (Cytotoxic Lymphomas): Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.
Subjects must have failed at least one prior systemic regimens.
Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.
Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification \[Swerdlow 2016\]).
For Part A only, evaluable disease is acceptable.
For Part B2 only, evaluable by the following response criteria as documented during Screening:
For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT/positron emission tomography (PET) scan defined as at least one node measuring \>1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).
For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).
For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).

Exclusion Criteria

Disease-specific Exclusion Criteria; LGLL and ANKL:
A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The following exclusion criteria apply to all subjects:
Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
Active or suspected malignant central nervous system involvement.
Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
Active known second malignancy.
Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
Hepatitis B infection (hepatitis B virus surface antigen \[HBsAg\] positive), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.
History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.
Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.
Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting inclusion criteria).
Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Irvine?

Yes, this clinical trial (NCT05475925) has an active research site in Irvine, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Large Granular Lymphocytic Leukemia Treatment Options in Irvine, CA

If you're searching for large granular lymphocytic leukemia treatment options in Irvine, CA, this clinical trial (NCT05475925) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Irvine research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced large granular lymphocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all large granular lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

More Leukemia Trials in Irvine, CA

See all leukemia clinical trials recruiting in Irvine — not just this study.

Browse Leukemia Trials in Irvine →

Browse More Trials by Condition

Leukemia TrialsHeart Attack TrialsRheumatoid Arthritis TrialsPulmonary Hypertension TrialsInterstitial Cystitis TrialsMyocardial Infarction TrialsAll Conditions →

Ready to Join in Irvine?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Irvine, CA