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New treatment option for Non-Hodgkin Lymphoma Refractory/ Relapsed
Official title Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL
ClinicalTrials.gov ID: NCT07271121
What this study is testing
- What it's testing
- This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 75
You may be able to join if
- Eligible patients with a diagnosis of aggressive NHL:
- Patients after progression on at least one standard chemotherapy and one salvage regimen or
- Patients considered for alloSCT but are found ineligible or
- Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive...
- Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
You likely can't join if
- Residual CNS disease
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage...
- History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
- Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies.
- Cardiac function: left ventricular ejection faction \<50% by echocardiogram,
See the full eligibility criteria
- Eligible patients with a diagnosis of aggressive NHL:
- Patients after progression on at least one standard chemotherapy and one salvage regimen or
- Patients considered for alloSCT but are found ineligible or
- Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
- CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry
- Age \> 18 year up to 75 years old (if deemed fit by treating investigator);
- Baseline absolute CD3+ T cell count by FACS ≥100/µl;
- ECOG performance score of 0-2 at screening;
- No active Hepatitis B, Hepatitis C, HIV I/II
- No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;
- Signed and dated informed consent, before conduct of any trial-specific procedure.
- Residual CNS disease
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
- History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
- Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies.
- Cardiac function: left ventricular ejection faction \<50% by echocardiogram,
- Renal function: Creatinine clearance \<50 mL/min/1.73 m2, by Cockcroft-Gault formula (Cockcroft and Gault 1976) for patients ≥18 years.
- Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \> 5 times upper limit of normal, unless due to lymphoma liver infiltration in the estimation of the investigator.
- Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy;
- Pregnant or breast-feeding females
- Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, Fludarabine/clofarabine or immunosuppressive (Calcineurin inhibitors) drugs and antibodies or investigational...
- Patients of child-bearing or fathering potential not willing to practice an effective form of birth control from the time of enrollment and for three months after dosing of the CARTs;
- Concurrent participation in another treatment trial that could interact with this trial, e.g. CAR T trials.
- Other investigational treatment within 4 weeks before CARTs infusion;
- Cerebral dysfunction, legal incapacity of adult patients;
- Committal to an institution on judicial or official order.
The study team makes the final eligibility decision.
Where it's taking place
- Amman, Jordan
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amman, Jordan. 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.