FDA Clears Study of Novel CAR T-Cell Therapy for Aggressive B-Cell Lymphoma


An investigational new drug application for IMPT-314 has been cleared by the FDA. A phase 1/2 trial investigating the agent will be initiated in early 2023.

The FDA has cleared an investigational new drug (IND) application for the bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, IMPT-314, for the treatment of patients with aggressive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).1

IMPT-314 targets the B-cell antigens CD19 and CD20. With the clearance of this IND, a phase 1/2 study is expected to begin in early 2023 to evaluate the safety of IMPT-314. Investigators will also assess the preliminary impact of disease activity of the agent.

According to Sumant Ramachandra, MD, PhD, an investigator-led study being done at the University of California, Los Angeles previously evaluated IMPT-314 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL; NCT04007029). Results demonstrated that 70% of patients achieved a complete response with significant durability of remission.2

“These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas. We look forward to initiating this phase 1/2 trial to help cancer patients who need new therapies," said Ramachandra, the president and chief executive officer of ImmPACT Bio, in the press release.

In the study, safety served as the primary end point and a total of 10 patients were given the CAR T-therapy. Overall, treatment with IMPT-134 demonstrated clinically meaningful results in patients with NHL, including subtypes of aggressive B-cell lymphoma, DLBCL, non-indolent or refractory follicular lymphoma (FL), and mantle cell lymphoma (MCL).

Findings from this study showed 9 of the 10 patients (90%) had an objective response. With a follow-up of more than 20 months, the median progression-free survival is 18.2 months. There was 1 patient who relapsed after 18 months in a complete response (CR). However, this patient returned to CR after being given a second dose of CART19/20 cells.

Looking at safety, patients only had grade 1 or no cytokine release syndrome and there were no patients with neurotoxicity or immune effector cell-associated neurotoxicity syndrome (ICANS).

Overall, this trial showed that treatment with these CAR T-cells were safe and effective in patients with relapsed/refractory NHL. Among the 10 patients, durable responses at low dosage levels were achieved.

According to the press release, 2 other platform logic-gated CAR technologies that will target solid tumors are being evaluated.

"[Yvonne] Chen, PhD, designed this bispecific CAR to address antigen escape, which is a key challenge for current approved CD19 therapies for hematological malignancies," Sarah Larson, MD, principal investigator of the trial, said in the press release. "We tested this anti-CD19/CD20 CAR-T cell therapy in patients with relapsed or refractory NHL and are encouraged about the potential of this therapy for patients."

ImmPACT Bio announces FDA clearance of IND for novel bispecific CAR to treat aggressive b-cell lymphoma. News release. ImmPACT Bio. January 24, 2023. Accessed January 24, 2023. https://prn.to/3XO7442
Larson SM, Walthers CM, Ji B, et al. CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR) in Naïve/Memory T Cells for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma [published online ahead of print, 2022 Nov 23]. Cancer Discov. 2022;CD-22-0964. doi:10.1158/2159-8290.CD-22-0964
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