The first patient with relapsed/refractory multiple myeloma has been treated with the investigational therapy bb21217, according to the clinical-stage company bluebird bio.
The treatment candidate bb21217, developed under a joint collaboration of bluebird bio and Celgene, is being tested in the two-part open-label Phase 1 CRB-402 study (NCT03274219), which is currently recruiting participants.
Bluebird also announced that Celgene has exercised its option to exclusively license the therapy, meaning that after the Phase 1 study, Celgene is solely responsible for the worldwide development and commercialization of bb21217.
The therapy belongs to the class of CAR T-cell therapies, where the immune T-cells are collected from a patient and then re-engineered in a laboratory to produce chimeric antigen receptors (CARs) that will more effectively recognize tumor cells.
The re-engineered CAR T-cells are then multiplied before they are infused back into the patient. Bb21217 targets the B-cell maturation antigen (BCMA), a protein selectively produced by malignant cells of multiple myeloma.
The Phase 1 CRB-402 study was designed to assess the safety and primary signs of efficacy of bb21217 in patients with relapsed or refractory multiple myeloma.
Its primary objective is to determine the maximum tolerated dose of bb21217 and define a recommended dosage for Phase 2 study. Secondary endpoints include disease response, measured according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.
In the first part of the trial, patients will receive escalating doses of bb21217 to assess the trial’s primary endpoint. In the second part, a dose expansion phase is initiated to evaluate the drug’s recommended Phase 2 dose for safety, tolerability, and clinical activity.
“bb21217, bluebird’s second oncology program to enter the clinic, complements bb2121, which has demonstrated encouraging safety and efficacy results in an ongoing Phase 1 trial. With bb21217, we manufacture a CAR T cell product enriched for ‘memory T cells’ – a long-lived, more potent T cell subtype – which in preclinical in vivo studies has shown improved anti-tumor activity,” Philip Gregory, chief scientific officer at bluebird bio, said in a news release.
“While the clinical data we have shared to date from our bb2121 program has shown deep and durable responses, we know that multiple myeloma is an aggressive and historically incurable cancer,” Gregory added. “With our partners at Celgene, we are excited to bring forward a second program reflecting our commitment to exploring all avenues to deliver cutting edge therapies to patients.”
Rupert Vessey, EVP and president, global research and early development at Celgene, said the advancement of bb21217 into the clinic “builds upon the success of our first-generation program and is one more testament to bluebird’s and Celgene’s combined leadership in the field of anti-BCMA CAR T therapies.
“We look forward to our continued partnership with bluebird to unleash the full potential of anti-BCMA CAR T therapies for patients living with historically incurable cancers,” Vessey said.