Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies
Summary
Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective. Eligibility: \- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy. Design: * Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests. * Participants may have eye and neurologic exams. * Participants will get a central venous catheter or a catheter in a large vein. * Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm. * The cells will be changed in a laboratory. * Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this. * All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone. * Participants will have many blood tests. They may repeat some screening exams. * Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams. * Participants will have follow-up for 15 years.
Timeline
- Start
- 2014-12-12
- Primary completion
- 2019-04-03
- Completion
- 2024-10-29
Publications
- Background Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.
- Background Bang S, Nagata S, Onda M, Kreitman RJ, Pastan I. HA22 (R490A) is a recombinant immunotoxin with increased antitumor activity without an increase in animal toxicity. Clin Cancer Res. 2005 Feb 15;11(4):1545-50. doi: 10.1158/1078-0432.CCR-04-1939.
- Background Kalos M, June CH. Adoptive T cell transfer for cancer immunotherapy in the era of synthetic biology. Immunity. 2013 Jul 25;39(1):49-60. doi: 10.1016/j.immuni.2013.07.002.
- Dreyzin A, Yates B, Shalabi H, Silbert SK, Wang HW, Yuan CM, Hoang CN, Culbert AA, Gava F, Nair MS, Giordani VM, Little L, Foley T, Nussenblatt V, Fry TJ, Stroncek DF, Highfill SL, Shah NN. Ten-year experience of CD22 CAR T cells for children and young adults with B-cell acute lymphoblastic leukemia. Blood Adv. 2026 Mar 10;10(5):1700-1712. doi: 10.1182/bloodadvances.2025017753.
- Silbert SK, Madan S, Holland EM, Steinberg SM, Little L, Foley T, Epstein M, Sarkisian A, Lee DW, Nikitina E, Kakumanu S, Ruppin E, Shalabi H, Yates B, Shah NN. A comprehensive analysis of adverse events in the first 30 days of phase 1 pediatric CAR T-cell trials. Blood Adv. 2023 Sep 26;7(18):5566-5578. doi: 10.1182/bloodadvances.2023009789.
- Jess J, Yates B, Dulau-Florea A, Parker K, Inglefield J, Lichtenstein D, Schischlik F, Ongkeko M, Wang Y, Shahani S, Cullinane A, Smith H, Kane E, Little L, Chen D, Fry TJ, Shalabi H, Wang HW, Satpathy A, Lozier J, Shah NN. CD22 CAR T-cell associated hematologic toxicities, endothelial activation and relationship to neurotoxicity. J Immunother Cancer. 2023 Jun;11(6):e005898. doi: 10.1136/jitc-2022-005898.
- Molina JC, Steinberg SM, Yates B, Lee DW, Little L, Mackall CL, Shalabi H, Shah NN. Factors Impacting Overall and Event-Free Survival following Post-Chimeric Antigen Receptor T Cell Consolidative Hematopoietic Stem Cell Transplantation. Transplant Cell Ther. 2022 Jan;28(1):31.e1-31.e9. doi: 10.1016/j.jtct.2021.10.011. Epub 2021 Oct 20.
- Masih KE, Ligon JA, Yates B, Shalabi H, Little L, Islam Z, Ombrello AK, Inglefield J, Nussenblatt V, Manion M, Khan J, Shah NN. Consequences of hemophagocytic lymphohistiocytosis-like cytokine release syndrome toxicities and concurrent bacteremia. Pediatr Blood Cancer. 2021 Oct;68(10):e29247. doi: 10.1002/pbc.29247. Epub 2021 Jul 26.
- Shah NN, Highfill SL, Shalabi H, Yates B, Jin J, Wolters PL, Ombrello A, Steinberg SM, Martin S, Delbrook C, Hoffman L, Little L, Ponduri A, Qin H, Qureshi H, Dulau-Florea A, Salem D, Wang HW, Yuan C, Stetler-Stevenson M, Panch S, Tran M, Mackall CL, Stroncek DF, Fry TJ. CD4/CD8 T-Cell Selection Affects Chimeric Antigen Receptor (CAR) T-Cell Potency and Toxicity: Updated Results From a Phase I Anti-CD22 CAR T-Cell Trial. J Clin Oncol. 2020 Jun 10;38(17):1938-1950. doi: 10.1200/JCO.19.03279. Epub 2020 Apr 14.