Aurigene reports promising phase-1 data for its CAR-T therapy against myeloma

Aurigene Oncology, a wholly-owned subsidiary of Dr.Reddy’s on Tuesday announced promising phase-1 results for its novel CAR-T cell therapy Ribrecabtagene autoleucel (DRL-1801) in patients with multiple myeloma.

The company said it got permission from the Indian drug regulator to begin a phase-2 trial.

The study called as SWASTH – is India’s first trial to test novel autologous (patient's own T-cell is used) targeting BCMA (B-cell maturation antigen) CAR-T therapy on patients with relapsed or refractory multiple myeloma.


The study reported initial results from the first 8 patients. All patients were heavily pre-treated with a median of 5.5 previous lines of treatment. Most patients had also received transplant in the past and had disease progression post-transplant.

"All 8 patients (100%) achieved clinical response, with 5/8 (62.5%) having achieved a stringent complete response," Aurigene said.

"With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients," the company added.

After reviewing the Phase 1 data, the Indian Regulatory Agency - the Drugs Controller General of India (DCGI), has given the nod to commence phase 2 part of the trial.

The results of phase-1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently.

“We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma,” said Dr. Murali Ramachandra, CEO, Aurigene Oncology.

Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector.

DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited, Bangalore.

CAR T-cell therapy is an immunotherapy that uses a person's own immune cells (T-cell) to fight cancer.