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Tests treatment safety and results for Non-Hodgkin Lymphoma, Adult
Official title Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
ClinicalTrials.gov ID: NCT05798897
What this study is testing
What is MT-601?
MT-601 is an investigational medicine, being studied as a potential treatment for non-hodgkin lymphoma, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\^6 cells (flat dosing).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- All applicable inclusion and
You likely can't join if
- must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment). Participants are eligible to be...
- Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and...
- Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid...
- 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...
- HL The following additional subtypes may be enrolled in disease specific cohorts during Dose Expansion (upon approval by Sponsor)
See the full eligibility criteria
Who can join
- All applicable inclusion and
What rules you out
- 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 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...
- 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)
- CLL/SLL
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Kansas City, Kansas, United States
- New York, New York, United States
- Austin, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; Kansas City, Kansas, United States; New York, New York, United States; Austin, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.