Cell therapy company Chimeric Therapeutics (ASX: CHM) has published positive interim data from a Phase 1A trial of its lead candidate CLTX CAR T in patients with heavily pre-treated, late-stage brain cancer.
Conducted at the City of Hope cancer research and treatment centre in the US, the trial administered the drug as a fourth line therapy for recurrent glioblastoma, compared to historical trials which have generally been limited to second line.
Patients treated across all four dose levels of the trial achieved a 55% disease control rate, exceeding expectations and historical disease control rates of up to 37% for patients treated in the second line.
A median survival rate of approximately 10 months was demonstrated in patients who achieved disease control compared to a seven month survival expectation for patients receiving first line therapy.
One patient exceeded 18 months of survival; two patients exceeded 14 months of survival; and three remain alive and are in follow-up treatment.
The interim results suggest that CLTX CAR T was generally well-tolerated, with no dose limiting toxicities and no cases of cytokine release syndrome (CRS) or tumour lysis syndrome (TLS).
CRS occurs when the immune system responds to infection or immunotherapy drugs more aggressively than it should.
TLS happens when tumour cells release their contents into the bloodstream, either spontaneously or in response to therapy, leading to conditions such as hyperuricemia (elevated uric acid in the blood), hyperkalemia (elevated potassium), hyperphosphatemia (elevated phosphorus) and hypocalcemia (reduced calcium).
Chimeric chief executive officer Jennifer Chow said the interim data was promising for ongoing studies.
“The CLTX CAR T dose escalation preliminary data is truly encouraging and has exceeded our expectations, particularly given that patients enrolled were heavily pretreated and very late stage,” she said.
“We have been able to show a median survival rate of 10 months with two patients demonstrating survival beyond 14 months… this strongly demonstrates the potential utility of CLTX CAR T for patients with this disease.”