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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia

Phase I/II Trial to Determine the in Vivo Engraftment, Safety and Clinical Activity of Allogeneic CIK Cells Transduced With a Transposon CD19-chimeric Antigen Receptor (CARCIK-CD19) Gene in Adult and Pediatric Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia (NCT05869279) is a Phase 1 / Phase 2 interventional studying B-cell NHL and CLL, sponsored by Fondazione Matilde Tettamanti Menotti De Marchi Onlus. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B-cell NHL, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 29 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: criteria apply: 1. Able and willing to provide written willing to sign a consent form and to comply with the study protocol according to International Conference on Harmonization (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, or Lansky \>50 for subjects \< 16 years of age ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: criteria apply: 1. Able and willing to provide written informed consent and to comply with the study protocol according to International Conference on Harmonization (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, or Lansky \>50 for subjects \< 16 years of age 9. Adequate cardiac and pulmonary function: ejection fraction (EF) by echo or MUGA \>40% and radial artery (RA) oxygen saturation \>92%. 10. Life expectancy (in the opinion of the Investigator) of \> 12 weeks 11. Adequate liver function: * Total bilirubin ≤ 2.0x ULN (≤ 3x ULN in patients with Gilbert's syndrome or documented liver involvement) * AST (aspartate aminotransferase) /ALT (alanine aminotransferase) 3x ULN or 5x for patients with evidence of liver involvement with lymphoma 12. Adequate bone marrow function to receive lymphodepleting chemotherapy at investigator judgment. 13. Adequate renal function: creatinine ≤1.5x ULN or creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥50 mL/min for adult patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function. For children, CrCl will be calculated by local institutional standard. 14. Females of childbearing potential (FCBP) subjects must: * Have a negative pregnancy test as verified by the local investigator * Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption from screening until at least 12 months following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. * Contraception methods must include one highly effective method including: surgical female sterilization, use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%) * Agree to abstain from breastfeeding during study participation and for at least 12 months following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. 15. Male subjects must: * Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. Exclusion Criteria: 1. 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 7. Major surgery or significant traumatic injury 28 days prior to CARCIK-CD19 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment 8. Patients with another active invasive malignancy with a life expectancy of less than 3 years 9. Significant cardiovascular disease (such as New York Heart Association (NYHA) Class II cardiac disease, congestive heart failure, myocardial infarction or cerebrovascular accident within 30 days prior to CARCIK-CD19 infusion, unstable arrhythmias, or unstable angina) 10. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary disease) and known autoimmune diseases 11. Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 2 weeks prior to CARCIK-CD19 infusion 12. Allogeneic or autologous Stem Cell Transplantation within 3 months prior to CARCIK-CD19 infusion, or Donor Lymphocytes (DLI) 13. Active GvHD Grades II-IV or extensive chronic Graft-versus-Host Disease (for patients who had previously been allotransplanted) 14. Prior treatment with CART cell therapy within 30 days before first study treatment administration (lymphodepletion) 15. Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo. 16. Ongoing corticosteroid use 25 mg/day (\> or 0.3 mg/kg for children) of prednisone or equivalent within 1 weeks prior to CARCIK-CD19 infusion 17. Administration of a live, attenuated vaccine within 4 weeks prior to CARCIK-CD19 infusion

Treatments Being Tested

BIOLOGICAL

CARCIK-CD19

allogeneic cytokine induced killer cells transduced with a transposon CD19-chimeric antigen receptor (CARCIK-CD19) gene

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05869279), the sponsor (Fondazione Matilde Tettamanti Menotti De Marchi Onlus), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05869279 clinical trial studying?

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05869279?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05869279?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05869279. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05869279. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.