NCT04825496

Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

Status unknown Phase 1 Last updated 21 September 2023

What this trial tests

Phase 1 trial testing ssCART-19 Cells in Relapsed or Refractory Acute Lymphoblastic Leukemia in 18 participants. Status unknown.

Timeline

9 April 2021

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	9 April 2021
Primary completion	31 December 2023
Estimated completion	31 December 2024
Sites	1 location across China

Drugs / interventions tested

• ssCART-19 Cells
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Relapsed or Refractory Acute Lymphoblastic Leukemia — all drugs for Relapsed or Refractory Acute Lymphoblastic Leukemia →

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd — full company profile →

Who can join

Adults 18 to 65, any sex, with Relapsed or Refractory Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineering strategies to safely drive CAR T-cells into the future.
   Rossi M, Breman E. · · 2024 · cited 25× · PMID 38962002 · DOI 10.3389/fimmu.2024.1411393
2. Advances in CAR-T cell therapy for hematologic and solid malignancies: latest updates from 2024 ESMO Congress.
   Huang H, Yu L, Weng H, Zhang W, et al · · 2024 · cited 16× · PMID 39639359 · DOI 10.1186/s13045-024-01639-1
3. IL-6 knockdown anti-CD19 CAR-T cells (ssCART-19) for patients with relapsed or refractory acute lymphoblastic leukemia: phase 1 trial.
   Xue SL, Liu MJ, Qian CS, Chen SN, et al · · 2025 · cited 2× · PMID 41145445 · DOI 10.1038/s41408-025-01397-4
4. Preemptive inotuzumab ozogamicin eradicated measurable residual disease in Ph-negative acute lymphoblastic leukemia relapsed post CD19 CART therapy.
   Huang SM, Wan CL, Cao HY, Li YY, et al · · 2023 · cited 2× · PMID 38084356 · DOI 10.1002/ccr3.8289
5. A systematic review and meta-analysis of shRNA-IL-6-engineered CAR-T cells for B-cell acute lymphoblastic leukemia: a stepping stone toward risk-free immunotherapy.
   Attia MS, Dyer B, McMillan N, Zunk M. · · 2026 · PMID 42012511 · DOI 10.1042/bsr20260143
6. Improving CAR T cell therapy against malignancies through gene knock-down/out strategies: a systematic review.
   Karimi A, Kazemi-Harikandei SZ, Alilou S, Salabat D, et al · · 2025 · PMID 41354926 · DOI 10.1186/s12935-025-04090-5