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MB-CART19.1 r/r CD19+ BCM
EU CTIS ID: 2024-513334-38-00
What this study is testing
The objective of this trial is to assess feasibility, safety and efficacy of ex vivo generated MB-CART19.1 in patients with relapsed or refractory CD19 positive B cell malignancies. Primary objective: To determine the recommended dose of MB-CART19.1.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients must have r/r CD19-expressing ALL or NHL/CLL and meet the following disease-specific criteria: All Cohorts: 1a) patients with >5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT) or have refractory disease activity precluding alloSCT at this time, or 1b) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with no evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1c) patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs. 1d) ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully cleared by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy). Pediatric aggressive NHL (1-17 years): 1e) patients after at least one salvage chemotherapy as bridge to alloSCT or 1f) patients ineligible for alloSCT or 1g) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with not evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1h) patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. Adult NHL: 1i) patients after at least one standard chemotherapy and one salvage regimen as bridge to alloSCT or 1j) patients who are ineligible for alloSCT or 1k) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with no evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1l) patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. CLL: 1m) patients with r/r disease after established and approved treatment options have failed. 1n) patients not eligible or appropriate for conventional alloSCT.
- CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL). Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available;
- Age ≥1 year (if deemed fit by treating investigator)
- Absolute CD3+ T cell count ≥100/μl
- ECOG performance score of 0-2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening
- No active Hepatitis B, Hepatitis C, HIV1/2
You likely can't join if
- Isolated CNS or testicular relapse in ALL
- Renal function: GFR ≤29 mL/min/1.73 m2 by CKD-EPI for patients ≥ 18 yrs (Levey et al. 2009) or creatinine clearance ≤29 mL/min/1.73 m2 by Schwartz formula (Schwartz et al. 1976) for patients <18 yrs of age
- Liver function: Patients with a serum bilirubin >3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukemic 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: a. Systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, tyrosine kinase inhibitors (TKI) and other kinase inhibitors (e.g. ibrutinib) within 7 days prior to leukapheresis; b. Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, calcineurin inhibitors, blinatumomab) or donor lymphocyte transfusions or radiation therapy within 14 days prior to leukapheresis, c. Previous treatment with CAR T cells (e.g. Kymriah®), d. Alemtuzumab within 3 months prior to leukapheresis, e. Exception: Intrathecal chemotherapy is allowed until 8 days prior to leukapheresis, with the exception of cytarabine. After leukapheresis, a single dose of intrathecal chemotherapy is allowed but should be discontinued 10 days prior to MB-CART19.1 infusion to limit risk of neurotoxicities
See the full eligibility criteria
Who can join
- Male or female patients must have r/r CD19-expressing ALL or NHL/CLL and meet the following disease-specific criteria: All Cohorts: 1a) patients with >5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT) or have refractory disease activity precluding alloSCT at this time, or 1b) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with no evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1c) patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs. 1d) ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully cleared by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy). Pediatric aggressive NHL (1-17 years): 1e) patients after at least one salvage chemotherapy as bridge to alloSCT or 1f) patients ineligible for alloSCT or 1g) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with not evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1h) patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. Adult NHL: 1i) patients after at least one standard chemotherapy and one salvage regimen as bridge to alloSCT or 1j) patients who are ineligible for alloSCT or 1k) patients who have relapsed post alloSCT no earlier than 100 days posttransplant, with no evidence of active GVHD, and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. 1l) patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion. CLL: 1m) patients with r/r disease after established and approved treatment options have failed. 1n) patients not eligible or appropriate for conventional alloSCT.
- CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL). Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available;
- Age ≥1 year (if deemed fit by treating investigator)
- Absolute CD3+ T cell count ≥100/μl
- ECOG performance score of 0-2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening
- No active Hepatitis B, Hepatitis C, HIV1/2
- No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential
- Signed and dated informed consent/assent by patients and/or parents, before conduct of any trial-specific procedure.
What rules you out
- Isolated CNS or testicular relapse in ALL
- Renal function: GFR ≤29 mL/min/1.73 m2 by CKD-EPI for patients ≥ 18 yrs (Levey et al. 2009) or creatinine clearance ≤29 mL/min/1.73 m2 by Schwartz formula (Schwartz et al. 1976) for patients <18 yrs of age
- Liver function: Patients with a serum bilirubin >3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukemic 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: a. Systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, tyrosine kinase inhibitors (TKI) and other kinase inhibitors (e.g. ibrutinib) within 7 days prior to leukapheresis; b. Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, calcineurin inhibitors, blinatumomab) or donor lymphocyte transfusions or radiation therapy within 14 days prior to leukapheresis, c. Previous treatment with CAR T cells (e.g. Kymriah®), d. Alemtuzumab within 3 months prior to leukapheresis, e. Exception: Intrathecal chemotherapy is allowed until 8 days prior to leukapheresis, with the exception of cytarabine. After leukapheresis, a single dose of intrathecal chemotherapy is allowed but should be discontinued 10 days prior to MB-CART19.1 infusion to limit risk of neurotoxicities
- Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment related toxicities
- Isolated CNS lymphomas
- Active solid brain metastases or history of solid brain metastases
- 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
- BMI ≥ 30
- Pulmonary function: Patients with pre-existing severe lung disease or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray
- Cardiac function: Pediatric patients: fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography, adult patients: left ventricular ejection fraction <50% by echocardiography
The study team makes the final eligibility decision.
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.