CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- Up to 21 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Donors that meet eligibility criteria will be consented to undergo two separate collections: 1) G-CSF mobilized stem cell graft via apheresis for progenitor cell infusion and 2) Non-mobilized peripheral blood mononuclear cells (PBMC) via apheresis for subsequent CAR T-cell manufacturing and DLI if needed."
- "Treatment will include a conditioning chemotherapy preparative regimen followed by infusion of TCRαβ/CD19 B cell depleted progenitor cell infusion on day 0."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether it is safe and possible to give special cancer-fighting T cells after a blood cell transplant from a partly matched family member. It is for patients age 21 or younger with high-risk blood cancers, including CD19-positive B-cell ALL, a type of leukemia. CD19 is a marker on some cancer cells that the T cells target.
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be age 21 or younger.
- Patients must have a high-risk blood cancer for which a donor transplant is standard care. This includes certain CD19-positive B-cell leukemias.
- Any past leukemia in the brain or spinal cord must have been treated and show no signs of disease there.
- Patients must meet the study’s limits for heart, kidney, lung, and liver function, and ability to do daily activities.
- Sexually active patients must agree to use birth control until 6 months after the T-cell treatment.
- Donors must be family members age 18 or older, match at least 4 of 8 tissue markers, and test negative for HIV.
- Donors must meet donation rules or have a study doctor document an urgent medical need.
- Sexually active donors must agree to use birth control until 2 weeks after the steps to prepare and collect their blood cells are done.
Who can't join
- Patients cannot have a suitable fully matched sibling donor or fully matched unrelated donor available in time.
- Patients cannot have another active cancer besides the one being treated with this transplant.
- Patients cannot have had a blood-forming cell transplant from another person before.
- Patients cannot be pregnant or breastfeeding. Those who could become pregnant need a negative pregnancy test within 14 days before joining.
- Patients cannot have a severe current infection caused by bacteria, fungi, or viruses that is not controlled.
- Donors cannot be pregnant or breastfeeding. Female donors need a negative pregnancy test within 14 days before joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Recipient * Age less than or equal to 21 years * High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to): * High risk CD19+ B cell ALL in CR1 or CR2 * Any CD19+ B-cell ALL in CR3 or subsequent * If prior CNS leukemia, it must be treated and in CNS CR * Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25% * Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2 * Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing * Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A) * Bilirubin ≤ 3 times the upper limit of normal for age * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age Donor * At least single haplotype matched (≥ 4 of 8) family member * At least 18 years of age * HIV negative * If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure * Regarding donation eligibility, is identified as either: * Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR * Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271 Exclusion Criteria: Recipient * Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame * Any other active malignancy other than the one for which this HCT is indicated * Received a prior allogeneic HCT at any time * Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment * If sexually active, agreement to use birth control until 6 months after T cell infusion * Breast feeding * Any severe current uncontrolled bacterial, fungal or viral infection Donor * Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female * If female, breast feeding
Study sites (1)
TN
- St. Jude Children's Research Hospital · Memphis, TN 38105Swati Naik, MBBS · Study contact · 888-226-4343 · referralinfo@stjude.orgSwati Naik, MBBS · Principal investigatorMore trials in Memphis