huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

Summary

This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces. In Stage 1, dose-finding studies will be conducted in 3 cohorts: 1. Aggressive B cell NHL 2. Low burden ALL 3. High burden ALL In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2: 1. Cohort 2A, CAR-naïve (n=10): patients who have never received CD19 CAR-T cell therapy. 2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.

Timeline

Start

2017-11-03

Primary completion

2023-03-23

Completion

2024-03-23

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to slow enrollment and end of funding”

Publications

• Gauthier J, Liang EC, Huang JJ, Kimble EL, Hirayama AV, Fiorenza S, Voutsinas JM, Wu QV, Jaeger-Ruckstuhl CA, Pender BS, Kirchmeier DR, Torkelson A, Braathen K, Basom R, Shadman M, Kopmar NE, Cassaday RD, Riddell SR, Maloney DG, Turtle CJ. Phase 1 study of CD19 CAR T-cell therapy harboring a fully human scFv in CAR-naive adult patients with B-ALL. Blood Adv. 2025 Apr 22;9(8):1861-1872. doi: 10.1182/bloodadvances.2024015314.

Drugs

Indications