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2024-05-22T07:32:20.000Z

Anti-CD30 CAR T-cell consolidation after auto-HSCT in patients with high-risk CD30+ lymphoma: results from a phase I trial

May 22, 2024
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Learning objective: After reading this article, learners will be able to cite a new development in the treatment of lymphoma.

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High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-HSCT) is the standard of care for patients with relapsed Hodgkin lymphoma.1 There is a need for alternative consolidation strategies after auto-HSCT in patients at a high risk of relapse. As previously covered by the Lymphoma Hub, anti-CD30 chimeric antigen receptor (CAR) T-cell therapy could be a promising posttransplant consolidation therapy for patients with CD30+ Hodgkin and non-Hodgkin lymphoma who are at high risk of relapse.1

Recently, results were published from a phase I trial (NCT02663297) assessing the safety of anti-CD30 CAR T-cell therapy as consolidation after auto-HSCT in patients with high-risk CD30+ lymphoma by Grover et al. in The Lancet Haematology. We summarize the key findings below.

Study design and patient population1

  • Multicenter, single-arm, phase I dose escalation trial.
  • Included patients aged ≥3 years with relapsed high-risk classical Hodgkin lymphoma or CD30+ non-Hodgkin lymphoma who were eligible for high-dose chemotherapy and auto-HSCT.
  • Patients underwent conditioning with carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by auto-HSCT.
  • Patients received a single dose of CAR T-cells at one of three dose levels:
    • Dose level 1: 2 × 107 cells/m2
    • Dose level 2: 1 × 108 cells/m2
    • Dose level 3: 2 × 108 cells/m2
  • The primary endpoints were the maximum tolerated dose of CAR T-cells, safety, and tolerability.
  • Secondary endpoints included progression-free survival and overall survival.

Key findings1

Patient characteristics

  • In total, 18 patients received treatment, of which 11 had Hodgkin lymphoma, six had T-cell lymphoma, and one had grey zone lymphoma.
  • The median age was 43 years (range, 16–76 years).
  • Four, five, and nine patients were treated at Dose levels 1, 2, and 3, respectively.

Safety

  • No dose-limiting toxicities were observed; Dose level 3 was established as the maximum tolerated dose
  • No treatment-related deaths occurred.
  • One patient treated at Dose level 3 experienced Grade 1 cytokine release syndrome (Table 1).

Table 1. Treatment-emergent adverse events*

Treatment-emergent adverse events, n

Grade 12

Grade 3

Grade 4

Anemia

1

1

0

Aspartate aminotransferase increased

4

0

0

Cytokine release syndrome

1

0

0

Diarrhea

3

0

0

Dizziness

2

0

0

Fatigue

3

0

0

Headache

2

0

0

Hypocalcemia

2

0

0

Lymphocyte count decreased

6

2

0

Nausea

6

0

0

Neutrophil count decreased

3

0

1

Platelet count decreased

4

1

0

Rash maculopapular

1

1

0

Vomiting

2

0

0

White blood cell count decreased

4

2

0

*Adapted from Grover, et al.1

Efficacy

  • After a median follow-up of 48.2 months, 44% of patients relapsed (Dose level 1, n = 3; Dose level 2, n = 1; Dose level 3, n = 4).
  • Median progression-free survival was 32.3 months and not reached for all treated patients and patients with Hodgkin lymphoma, respectively.
  • The median overall survival was not reached for all treated patients.
  • The 2-year survival rates are shown in Figure 1.
  • All patients with Hodgkin lymphoma are alive, while five patients with T-cell lymphoma have died (relapse, n = 4; unrelated lung cancer, n = 1).

Figure 1. 2-year progression-free survival and overall survival rates*

*Adapted from Grover, et al.

 

Key learnings
  • Results from this trial suggest that consolidation with anti-CD30 CAR T-cells following BEAM and auto-HSCT is feasible in patients with CD30+ lymphoma who are at high risk of relapse.
  • Treatment was well-tolerated, and preliminary clinical activity was observed in patients with Hodgkin lymphoma.
  • Future trials are needed to compare this approach with maintenance therapy with brentuximab vedotin or checkpoint inhibitors.

  1. Grover NS, Hucks G, Riches ML, et al. Anti-CD30 CAR T cells as consolidation after autologous haematopoietic stem-cell transplantation in patients with high-risk CD30+lymphoma: a phase 1 study. Lancet Haematol. 2024;11(5):e358-e367. DOI: 1016/S2352-3026(24)00064-4

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