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New treatment option for B-cell NHL
Official title Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05869279
What this study is testing
What is CARCIK-CD19?
CARCIK-CD19 is an investigational medicine, being studied as a potential treatment for b-cell nhl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- criteria apply:
- Able and willing to provide written informed consent and to comply with the study protocol according to International Conference on Harmonization...
- Ineligibility to commercially available CAR-T cells
- Age limits: children (1-17 years old) and adults (≥18 years old)
- Availability of an at least haploidentical (i.e. 4/8 HLA matched by allele typing) familial donor willing to and eligible for blood donation
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...
- Patients with an active infection with Hepatitis B. However, patients with a controlled (treated) hepatitis will be allowed if the all the following...
- 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
- Patients with an active hepatitis C virus (HCV) infection. However, patients with successfully treated chronic HCV infection will be allowed if they...
See the full eligibility criteria
Who can join
- criteria apply:
- 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.
- Ineligibility to commercially available CAR-T cells
- Age limits: children (1-17 years old) and adults (≥18 years old)
- Availability of an at least haploidentical (i.e. 4/8 HLA matched by allele typing) familial donor willing to and eligible for blood donation
- 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...
- 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...
- 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)...
- Eastern Cooperative Oncology Group (ECOG) performance status equal to 2 or less for subject ≥ 16 years of age, or Lansky \>50 for people \< 16 years of age
- Adequate cardiac and pulmonary function: ejection fraction (EF) by echo or MUGA \>40% and radial artery (RA) oxygen saturation \>92%.
- Life expectancy (in the opinion of the Investigator) of \> 12 weeks
- 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
- Adequate bone marrow function to receive lymphodepleting chemotherapy at investigator judgment.
- 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...
- Females of childbearing potential (FCBP) people 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...
- 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...
- 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...
- Male people 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...
What rules you out
- 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...
- 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
- 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...
- 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...
- Rapidly progressive disease that in the estimation of the investigator and sponsor could affect compliance with the protocol or interpretation of results
- Active CNS lymphoma
- 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
- Patients with another active invasive malignancy with a life expectancy of less than 3 years
- 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...
- 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...
- 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...
- Allogeneic or autologous Stem Cell Transplantation within 3 months prior to CARCIK-CD19 infusion, or Donor Lymphocytes (DLI)
- Active GvHD Grades II-IV or extensive chronic Graft-versus-Host Disease (for patients who had previously been allotransplanted)
- Prior treatment with CART cell therapy within 30 days before first study treatment administration (lymphodepletion)
- 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.
- 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
- Administration of a live, attenuated vaccine within 4 weeks prior to CARCIK-CD19 infusion
The study team makes the final eligibility decision.
Where it's taking place
- Bergamo, BG, Italy
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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergamo, BG, Italy. 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.