NCT03098355

Interleukin-2 Following 4SCAR19/22 T Cells Targeting Refractory and/or Recurrent B Cell Malignancies

Withdrawn Phase 1, PHASE2 Last updated 18 March 2024

What this trial tests

Phase 1, PHASE2 trial testing 4SCAR19/22 T cells in B-Cell Leukemia. Withdrawn.

Timeline

30 December 2017

Primary endpoint
15 December 2022

31 December 2023

Quick facts

Lead sponsor	Zhujiang Hospital
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 December 2017
Primary completion	15 December 2022
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• 4SCAR19/22 T cells — full drug profile →
• Interleukin-2

Conditions studied

• B-Cell Leukemia — all drugs for B-Cell Leukemia →
• B-Cell Lymphoma — all drugs for B-Cell Lymphoma →

Sponsor

Zhujiang Hospital

Who can join

Adults 1 to 14, any sex, with B-Cell Leukemia or B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinical studies of CD19 CAR-T cells in the treatment of blood and lymphatic system tumors have achieved unprecedented successes. Because of the heterogeneity of the tumor, patients often carry CD19-negative tumor cell clones that express alternative target antigens (such as CD22, CD20 and CD123). In order to effectively eradicate all tumor clones and prevent recurrence, alternative tumor antigens besides CD19 are considered for CAR-T cell targeting. In this tudy, autologous T cells are genetically modified with 4th generation anti-CD19 and anti-CD22 CARs (4SCAR19/22) using lentiviral vectors. For safety consideration, the 4SCAR is engineered with an inducible caspase 9 self-withdrawal genetic design that allows for rapid elimination of the infused CAR-T cells. Interleukin-2 has been shown to boost immune response against leukemia cells. The serum interleukin-6 level will be monitored and when it returns to normal range by day 28 after CAR-T cell infusion, patients will receive subcutaneous injection of interleukin-2, and evaluated for 24 months for safety, efficacy and persistence of CAR T cells.

Publications & conference data

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

1. Engineered T Cell Therapy for Cancer in the Clinic.
   Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250
2. Next generation chimeric antigen receptor T cells: safety strategies to overcome toxicity.
   Yu S, Yi M, Qin S, Wu K. · · 2019 · cited 208× · PMID 31429760 · DOI 10.1186/s12943-019-1057-4
3. Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
   Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
4. CAR T-Cell Therapy in Hematological Malignancies.
   Haslauer T, Greil R, Zaborsky N, Geisberger R. · · 2021 · cited 115× · PMID 34445701 · DOI 10.3390/ijms22168996
5. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
6. The expansion of targetable biomarkers for CAR T cell therapy.
   Townsend MH, Shrestha G, Robison RA, O'Neill KL. · · 2018 · cited 60× · PMID 30031396 · DOI 10.1186/s13046-018-0817-0
7. Clinical trials of CAR-T cells in China.
   Liu B, Song Y, Liu D. · · 2017 · cited 55× · PMID 29058636 · DOI 10.1186/s13045-017-0535-7
8. Immune Cell Hacking: Challenges and Clinical Approaches to Create Smarter Generations of Chimeric Antigen Receptor T Cells.
   Elahi R, Khosh E, Tahmasebi S, Esmaeilzadeh A. · · 2018 · cited 49× · PMID 30108584 · DOI 10.3389/fimmu.2018.01717