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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
ClinicalTrials.gov ID: NCT04544592
What this study is testing
What is CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells?
CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
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 phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
- 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 31 to 30
You may be able to join if
- Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.
- Provision of signed and dated consent form from parent or guardian (patients \ 18), or legally authorized representative (patient \>18 who lack...
- Willingness to participate in long term follow up study.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Males OR non-pregnant, non-breastfeeding females. o Patients of child-bearing potential or capable of fathering a child must agree to use highly...
You likely can't join if
- Evidence of rapidly progressive disease without adequate salvage/bridging regimens as determined by the investigator.
- Active Graft-versus-Host Disease (GvHD).
- Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance...
- Evidence of severe organ dysfunction as defined by:
- Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as...
- Baseline oxygen saturation of ≤ 90% on room air
See the full eligibility criteria
- Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.
- Provision of signed and dated consent form from parent or guardian (patients \ 18), or legally authorized representative (patient \>18 who lack decision-making capacity); Pediatric patients will be included in...
- Willingness to participate in long term follow up study.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Males OR non-pregnant, non-breastfeeding females. o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration...
- Aged 31 days to 30 years (inclusive) at time of consent and enrollment.
- Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:
- Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both. Cohort One Criteria:
- Meets any one of the following conditions:
- Relapsed two or more times
- Relapsed at any time after allogeneic BMT
- Refractory to standard therapy as determined by the treating physician
- Meets criteria for BMT but is ineligible as determined by the treating physician Patient and/or parents declining BMT options and would prefer CAR-T Therapy.
- Non-Hodgkin Lymphoma includes all of the following:
- Diffuse large B-cell lymphoma (DLBCL)
- Burkitt Lymphoma
- Intermediate lymphoma between Burkitt and DLBCL
- Primary Mediastinal B-cell Lymphoma (PMBL)
- Follicular lymphoma
- High grade B cell lymphoma
- Transformed lymphoma Cohort Two Criteria:
- B-ALL in first relapse with any one of the following conditions:
- High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation/deletion.
- Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.
- Down syndrome.
- Minimal residual disease (MRD) positivity of \> 0.01% by FACS or \> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.
- Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.
- Performance score (Lansky or Karnofsky) of 50% or better;
- Unable to or declined to receive commercially available CD19 CAR-T Therapy.
- Evidence of rapidly progressive disease without adequate salvage/bridging regimens as determined by the investigator.
- Active Graft-versus-Host Disease (GvHD).
- Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.
- Evidence of severe organ dysfunction as defined by:
- Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant...
- Baseline oxygen saturation of ≤ 90% on room air
- Transaminases \> 10x upper limit of normal (ULN) or bilirubin \>2x the ULN, unless thought to be related to primary disease
- Estimated Cr clearance \<60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
- Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.
- Known HIV infection, or active Hepatitis B or active Hepatitis C infection.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
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, 31 days to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. 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.