Is NCT05798897 recruiting in Duarte, CA?

Yes, NCT05798897 is currently recruiting participants at its Duarte, CA location. This non-hodgkin lymphoma, adult clinical trial is actively enrolling qualified participants.

How do I join the non-hodgkin lymphoma, adult clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-Hodgkin Lymphoma, Adult Clinical Trial in Duarte, CA

Who Can Participate

Inclusion Criteria

All applicable inclusion and

Exclusion Criteria

must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment). Participants are eligible to be included in the study only if all of the following criteria apply and the participant, in the judgement of the Investigator, is an appropriate candidate for experimental therapy: General:

Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF. Disease Specific:

Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid neoplasms

Enrollment of the following subtypes will be eligible:

LBCL including diffuse large B cell lymphoma, primary mediastinal B cell lymphoma (PMBCL), high grade B cell lymphoma (HGBL), T cell rich B cell lymphoma and transformed indolent lymphoma (transformed iNHL)

HL The following additional subtypes may be enrolled in disease specific cohorts during Dose Expansion (upon approval by Sponsor)

CNS lymphoma

CAR T cell refractory

Must have measurable disease as per 2014 Lugano criteria or 2018 iwCLL criteria. Participants with splenic MZL must have measurable splenomegaly on imaging or evidence of bone marrow involvement. Prior Treatments

Participants who are R/R, are intolerant to, or are considered ineligible for systemic standard of care anticancer treatments, including at least 2 prior therapies. Participants who refuse standard of care treatments may also be considered if documentation is provided that he/she has been made aware of all therapeutic options.

For participants with LBCL, FL, and MCL: Have received CD19-directed CAR T cell therapy and relapsed ≥ 30 days or attained an incomplete response as the best response within 1 year after CAR T cell administration. Participants who refuse or are ineligible for CAR T cell therapy are eligible for this study. Note: during Dose Expansion, a specific cohort may be enrolled to evaluate participants who were refractory to CD19-directed CAR T cell therapy. Health Status

Karnofsky score of ≥70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Life expectancy ≥12 weeks

Adequate blood, liver, renal and cardiac function:

Hematology: Hemoglobin ≥ 7.0 g/dL (can be transfused), absolute lymphocyte count (ALC) ≥ 300/μL, (prior to apheresis only), absolute neutrophil count (ANC) ≥ 750/μL and platelet count ≥ 50,000/μL (prior to the conditioning regimen only)

Liver: Bilirubin ≤ 1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome 3X); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3X ULN

Renal: Serum creatinine ≤ 1.5X ULN or measured or calculated creatinine clearance ≥ 50 mL/min (prior to the conditioning regimen)

Cardiac: left ventricular ejection fraction ≥ 45% (prior to the leukapheresis) Sex

Female: Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (i.e., with a failure rate of \< 1% per year), preferably with low user dependency during the intervention period and for at least 6 months after the last infusion of MT-601 and agrees not to donate eggs (i.e., ova and oocytes) for the purpose of reproduction during this period

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-601: Refrain from donating sperm PLUS either: Be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception as a condom may break or leak Exclusion Criteria:

Patients are excluded from the study if any of the following criteria apply: Disease-related

Evidence of bulky disease at the time of the conditioning regimen (≥ 10 cm in diameter for LBCL or HL and \> 6 cm for other subtypes)

Untreated or ongoing treatment for CNS lymphoma or completed treatment within 2 weeks of apheresis (Note: May be allowed in Dose Expansion if disease specific cohort for CNS lymphoma is opened)

Refractory to CAR T therapy defined as a best response of stable disease or disease progression (Note: May be allowed in Dose Expansion if disease specific cohort for CAR T cell therapy refractory is opened)

Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression Medical Conditions

Primary immunodeficiency

Severe or uncontrolled autoimmune disorder

History or presence of clinically relevant CNS pathology such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Unresolved immune effector cell-associated neurotoxicity syndrome (ICANS) from prior CAR T cell administration. Consideration for Grade 1 may be made after discussion with the Medical Monitor

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast, and/or prostate) unless disease free for at least 3 years

Cardiac conditions:

Medically uncontrolled hypertension (≥ 160 mmHg systolic blood pressure or ≥ 100 mmHg diastolic blood pressure)

Congestive heart failure Class ≥ II as defined by the New York Heart Association

Acute coronary syndrome (including unstable angina, coronary artery stenting, or angioplasty, bypass grafting within prior 6 months)

History or evidence of current, uncontrolled, clinically significant, unstable arrhythmias

Oxygen saturation at room air \< 92%

Participant has known human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection

Acute bacterial, viral, fungal infection requiring systemic therapy (uncomplicated urinary tract infection and bacterial pharyngitis are permitted if responding to therapy)

History of severe allergic reactions to any of the study intervention components including conditioning regimen, dimethyl sulfoxide (DMSO) or to tocilizumab

Clinically significant reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline

Participants with Grade 2 neuropathies due to prior treatment will be allowed on study.

Participants with clinical nonsignificant toxicities, such as alopecia, will be allowed on study. Prior/Concomitant Therapy Prior to Apheresis:

Receipt of allogeneic hematopoietic cell transplant (HCT) within 12 months; on immunosuppression or with evidence of donor/mixed chimera

Receipt of autologous HCT within 3 months

Treatment with CD19-directed CAR T cell therapy within 3 months

Treatment with bispecific antibody within 1 month

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Treatment with monoclonal antibodies impacting T cell function within 14 days

Treatment with systemic immunosuppression including systemic corticosteroids (unless ≤5 mg/day oral prednisone or steroid equivalent) within 14 days

Treatment with chemotherapy within 7 days Prior to the conditioning regimen:

Treatment with a live, attenuated vaccine within 4 weeks

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Treatment with chemotherapy or biologics/monoclonal antibodies within 14 days

Treatment with radiation therapy within 7 days

Treatment with a tyrosine kinase inhibitor (TKI) within 7 days or 5 half-lives (whichever is longer) before conditioning regimen

Hematopoietic growth factors \<2 days At either time:

Treatment with experimental CAR T cell product unless approved by Medical Monitor

Treatment with other cancer therapy including investigational agents that do not fit in the above categories within 14 days

Major surgery within 14 days Other

Pregnant or lactating

Any other issue which, in the opinion of the treating physician, would make the participant ineligible for the study

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 Duarte?

Yes, this clinical trial (NCT05798897) has an active research site in Duarte, 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.

Non-Hodgkin Lymphoma, Adult Treatment Options in Duarte, CA

If you're searching for non-hodgkin lymphoma, adult treatment options in Duarte, CA, this clinical trial (NCT05798897) 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 Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-hodgkin lymphoma, adult 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 non-hodgkin lymphoma, adult clinical trials near you to find additional studies recruiting in your area.

Non-Hodgkin Lymphoma, Adult Clinical Trial in Duarte, CA

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About This Non-Hodgkin Lymphoma, Adult Study in Duarte