Engineered immune cells take on Hard-to-Treat blood cancers
NCT ID NCT06191887
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new type of CAR T-cell therapy called MC10029 for people with B-cell blood cancers that have returned or not responded to treatment. The therapy involves taking a patient's own immune cells, modifying them in the lab to target a protein called BAFFR on cancer cells, and infusing them back along with chemotherapy. The main goals are to find the safest dose and to watch for side effects in 27 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAFFR-targeting CAR T cells (MC10029) with chemotherapy (fludarabine and cyclophosphamide)
- What this could lead to
- If it works, this could offer a new treatment option for patients with B-cell cancers that have come back or stopped responding to standard therapy.
- What could go wrong
- This is a very early (Phase 1) trial with only 27 participants, so it is mainly checking safety and dosing. The treatment may not work, and side effects like cytokine release syndrome or nervous system problems are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2024
- Expected to finish
-
Dec 2040
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * PRE-REGISTRATION: Age ≥ 18 years * PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL/SLL * For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology: * Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as: * Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as: * Demonstration of progressive or stable disease by PET/CT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma * PRE-REGISTRATION: Disease Specific prior lines of therapies below: * For CLL/SLL, patients must have received ≥ two prior lines of therapy, and/or ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months * These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20). * For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. * NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period. * For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor. * NOTE: Prior CD19 directed CART must have a 100-day washout period. * For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. * NOTE: Prior CD19 directed CART must have a 100-day washout period. * For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator. * NOTE: Prior failed CD19 directed CART must have a 100-day washout period * For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20. * 100-day washout period starts from the date of the last prior CAR-T infusion. * PRE-REGISTRATION: Measurable disease * REGISTRATION: Positive BAFFR test * REGISTRATION: Measurable disease * REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * REGISTRATION: Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration * REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration * REGISTRATION: Platelet count ≥100,000/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration * REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration * REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration * REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR) /activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration * Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT/INR measurements \> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study * REGISTRATION: Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration * REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures * REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45% * REGISTRATION: Patients must have pulse ox measurements of \> 92% on room air * REGISTRATION: Willingness to provide mandatory blood specimens for correlative research * REGISTRATION: Willing to return to enrolling institution for study follow-up Exclusion Criteria: * PRE-REGISTRATION: Prior solid organ transplantation * PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration * PRE-REGISTRATION: Prior anti-BAFF-R therapies * PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy * PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration * PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R * PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration * PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to: * Previous or concurrent malignancy * Ongoing or active infection * Psychiatric illness/social situations * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \* Persons of childbearing potential who are pregnant or breastfeeding * Life Expectancy of \< 6 weeks * Persons requiring systemic corticosteroids (\>10 mg prednisone or equivalent per day) and/or other immunosuppressive therapy. Patients are allowed to use topical corticosteroids * Any other conditions that would limit compliance with study requirements * PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by malignancy (CSF or imaging) with still active disease. Note: Patients with a history of CNS involvement resolving after treatment and without active disease will be considered eligible if other inclusion criteria are met * PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement * PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration * PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT * PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients * PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure * REGISTRATION: Eligible for auto-HCT based on investigator judgement * REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment * REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility * REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration * REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding * REGISTRATION: Life expectancy of \< 6 weeks
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Can engineered immune cells lock in remission for aggressive lymphoma?
- Can a Multi-Drug combo outsmart resistant lymphoma?
- Engineered immune cells take aim at Hard-to-Treat lymphomas