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Allogeneic CARCIK-CD19 in adults/pediatric B-cell Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
EU CTIS ID: 2023-505511-20-00
What this study is testing
Phase I To identify the recommended Phase 2 dose (RP2D) of allogeneic, HLA haploidentical familial CARCIK-CD19 cells in B-cell NHL Phase II To evaluate the efficacy of CARCIK-CD19 infusion in terms of overall response rate
- Phase I and Phase II (Integrated)- Other
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
- 1. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations. 2. Ineligibility to commercially available CAR-T cells 3. Age limits: children (1-17 years old) and adults (≥18 years old) 4. Availability of an at least haploidentical (i.e. 4/8 HLA matched by allele typing) familial donor willing to and eligible for blood donation 5. Histologically-confirmed mature B-cell neoplasia (NHL), according to according to WHO 2021 classification: • Eligible histologies include: indolent [follicular lymphoma (FL) or marginal zone lymphoma (MZL) nodal; extra-nodal; or splenic] or aggressive [diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBL), high-grade B cell lymphoma with MYC and BCL2 rearrangements (double-hit lymphoma), mantle cell lymphoma (MCL), including transformed B-cell NHL], CLL or lymphocytic lymphoma (LL). high-grade B cell lymphoma (HGBCL) NOS. Additional histologies including Burkitt lymphoma and Richter syndrome will be considered upon review with Sponsor. 6. Relapsed after or refractory to at least two prior lines of treatment, and no available treatment options that are expected to prolong survival (e.g. chemotherapy or high-dose chemotherapy/stem cell transplantation, commercially available CART cell therapy or other standard treatment) or patients refusing such treatments 7. At least one measurable target lesion, measurable as defined by Lugano 2014 classification (nodal: > 1.5 cm longest transverse diameter; extra-nodal: > 1 cm longest transverse diameter) by computerized tomography (CT) scan or presence of assessable disease (i.e. bone marrow or spleen) 8. Eastern Cooperative Oncology Group (ECOG) performance status equal to 2 or less for subject ≥ 16 years of age, ore Lansky >50 for subjects < 16 years of age
You likely can't join if
- Patients with clinically significant active viral, bacterial or fungal infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 2 weeks prior to CARCIK-CD19 infusion. 2) Patients with an active infection with Hepatitis B. However, patients with a controlled (treated) hepatitis will be allowed if the all the following criteria are met: • Anti-viral therapy for hepatitis B virus (HBV) must be given for at least 1 month prior to time of informed consent; • HBV viral load must be <2000 IU/mL (104 copies/mL) prior to time of informed consent; and • those on active HBV therapy with viral load <2000 IU/mL (104 copies/mL) should stay on the same anti-viral therapy throughout study treatment 3) Patients with an active hepatitis C virus (HCV) infection. However, patients with successfully treated chronic HCV infection will be allowed if they show a sustained virologic response at 12 weeks (SVR12) or 24 weeks (SVR24), and if there is a 4-week period between achieving sustained viral response (SVR12 or SVR24) and time of informed consent. 4) Patients with a positive serologic test or a positive molecular PCR test for human immunodeficiency virus (HIV) are eligible if asymptomatic, well controlled by the HAART therapy and no medically significant active infection is present 5) Rapidly progressive disease that in the estimation of the investigator and sponsor could affect compliance with the protocol or interpretation of results 6) Active CNS lymphoma
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, 18-64 years, 0-17 years, 65+ 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.