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The role of consolidative HSCT after CD19-targeted CAR T-cell therapy for ALL
Source: Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 21, 2025 · Captured 2026-09-09.
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Studies of second-generation CD19-targeted CAR T-cell approaches have shown that constructs using CD28-based costimulatory molecules result in a relatively short half-life of CAR T cells. This short half-life leads to very high rates of relapse unless HSCT is done soon after recovery from CAR T-cell toxicities. Therefore, treatments with CD28-targeted CAR T cells are considered bridging therapies, and HSCT is generally planned for eligible patients 4 to 8 weeks after the CAR T-cell procedure. Tisagenlecleucel and other CARs with 4-1BB costimulatory molecules have been shown to have significant levels of persistence, leading to long-term remission in 45% to 50% of patients without additional therapy. Up to 80% of relapses occur during the first year after CAR T-cell therapy and there is a window of deep remission. Because of this finding, some study groups have argued for planned HSCT during remission early after CAR T-cell infusion, either in all patients or in patients who have not had a previous HSCT. No randomized trials have addressed this issue, but some studies have addressed this question retrospectively.
Evidence (consolidative HSCT after CAR T-cell therapy):
CD28 CAR T-cell bridging approach.
CD28 CAR T-cell bridging approach.
A study examined 50 children and young adults who were treated with CD28-based CD19 CAR T-cell therapy.[183][Level of evidence C2]
Source links and citations
CD28 CAR T-cell bridging approach. › A study examined 50 children and young adults who were treated with CD28-based CD19 CAR T-cell therapy.[183][Level of evidence C2]
Twenty-one patients achieved an MRD-negative CR and underwent an allogeneic HSCT. In these 21 patients, the median OS was 70.2 months, and the 5-year EFS rate was 61.9%.
4-1BB CARs with varying approaches to HSCT.
4-1BB CARs with varying approaches to HSCT.
A study of 50 patients eligible for HSCT after 4-1BB-based CAR T-cell therapy reported the following results (PLAT-02 [NCT02028455] trial):[201]
Source links and citations
4-1BB CARs with varying approaches to HSCT. › A study of 50 patients eligible for HSCT after 4-1BB-based CAR T-cell therapy reported the following results (PLAT-02 [NCT02028455] trial):[201]
Patients who lost CAR T-cell function before 63 days after therapy had improved LFS if they underwent HSCT, compared with those who did not undergo HSCT (P = .01).
4-1BB CARs with varying approaches to HSCT. › A study of 50 patients eligible for HSCT after 4-1BB-based CAR T-cell therapy reported the following results (PLAT-02 [NCT02028455] trial):[201]
Patients with no prior history of HSCT had an improved LFS with a planned HSCT, with a trend toward significance (P = .09). This benefit was not evident in the 34 patients with a history of prior HSCT (P = .45).
4-1BB CARs followed by an intent to perform HSCT.
4-1BB CARs followed by an intent to perform HSCT.
In a study from China of 52 children who received either CD19- or CD22-targeted CAR T-cell therapy and underwent a planned HSCT at a median of 50 days after CAR T-cell infusion (range, 34–98 days; 48 MRD-negative and 4 MRD-positive patients at time of HSCT), the following results were reported:[202]
Source links and citations
4-1BB CARs followed by an intent to perform HSCT. › In a study from China of 52 children who received either CD19- or CD22-targeted CAR T-cell therapy and underwent a planned HSCT at a median of 50 days after CAR T-cell infusion (range, 34–98 days; 48 MRD-negative and 4 MRD-positive patients at time of HSCT), the following results were reported:[202]
The 1-year EFS rate was 73%, and the 1-year OS rate was 87.7%.
4-1BB CARs followed by an intent to perform HSCT. › In a study from China of 52 children who received either CD19- or CD22-targeted CAR T-cell therapy and underwent a planned HSCT at a median of 50 days after CAR T-cell infusion (range, 34–98 days; 48 MRD-negative and 4 MRD-positive patients at time of HSCT), the following results were reported:[202]
Although the survival rate of patients eligible to proceed to HSCT in remission was high, the analysis did not include patients who had a previous HSCT, patients who did not achieve remission with CAR T-cell infusions, and patients who were not eligible for HSCT after CAR T-cell therapy.
Studies cited in this source section
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