Kiromic Puts Gamma Delta T-Cells to the Test for Lung Cancer in Deltacel-01 Clinical Trial
Following up on World Lung Cancer Day, observed annually on the first of August, CGTLive® has decided to take a closer look at this novel cell therapy.
Kiromic BioPharma’s KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy, is currently being evaluated in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) for the treatment of non-small cell lung cancer (NSCLC).1 Following up on World Lung Cancer Day, observed annually on the August 1 by the clinician and patient communities, CGTLive® has decided to take a closer look at this novel cell therapy this month.
Deltacel-01 was initiated on November 7, 2023, and is led by principal investigator Jason J Luke, MD, FACP, an associate professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center. The trial takes the form of a dose escalation and dose expansion study. In the dose escalation portion, planned doses include 400x106, 800x106, and 1600x106 KB-GDT-01 cells and radiation. The low dose radiotherapy (LDRT) is given to selected tumor sites on Days 1 and 2 of the study at 1.0 Gy/fraction, and the first infusion of the cell therapy itself is given on Day 3. At Days 8 and 9, LDRT is given again and at Day 10 another infusion of Deltacel is given. According to an announcement made on August 9, 2024, Kiromic has treated 2 cohorts of 3 patients each in the first portion of Deltacel-01, and intends to move onto the dose expansion portion of the study in September 2024.
“We are pleased to have completed enrollment in Part 1 of our clinical trial,” Pietro Bersani, CPA, the chief executive officer of Kiromic, said in an August 2024 statement.1 “The favorable results of our GDT therapy, particularly with respect to progression-free survival (PFS), in the first 2 cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumors, and we look forward to launching Part 2 of this study.”
According to the clinicaltrials.gov page, which was most recently updated on December 15, 2023, Deltacel-01 is currently recruiting at Beverly Hills Cancer Center & Optima Diagnostic Imaging in California and University of Pittsburg School of Medicine in Pennsylvania. The study has an estimated primary completion date of October 2024 and an estimated study completion date of January 2027.
Deltacel-01's primary end point is the number of patients who experience adverse events (AEs) and/or dose limiting toxicities (DLTs), with DLTs defined as clinically significant grade 3 or great AEs that happen during the DLT assessment period and are not deemed to be caused by disease progression, intercurrent illness, or concomitant medication. The timeframe for the primary end point is from the first infusion of Deltacel to Day 40 or 30 days after the final infusion of Deltacel, depending on which occurs later. The trial’s secondary end points include the objective response rate (ORR), PFS, overall survival (OS), time to progression (TTP), time to treatment response (TTR), and the disease control rate (DCR). The time frame for ORR is from the first infusion of Deltacel though Month 24; the time frame for PFS is from the first infusion of Deltacel until evidence of disease progression, death, or Month 24; the time frame for OS is from first infusion of Deltacel until death or Month 24; the time frame for TTP is from the first infusion of Deltacel until evidence of disease progression or Month 24; the time frame for TTR is from the first infusion of Deltacel until evidence of disease response or Month 24; and the time frame for DCR is from the first infusion of Deltacel until evidence of disease response or stable disease or Month 24.
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Deltacel-01 is open to patients aged 18 years and older with histologically or cytologically confirmed stage 4 metastatic NSCLC. Participants must weigh at least 50 kg and have an Eastern Cooperative Oncology Group performance status of 0 to 1. Furthermore, patients must have experienced disease progression while on 2 or more standard of care therapies, including platinum-based chemotherapy and immune checkpoint inhibitors; must have 1 or more target lesion measurable by RECIST v1.1; and 6 months or more of life expectancy. Any patients with tumors with known actionable molecular alterations must have experienced disease progression while on target-directed molecular therapy and any patients with toxicity from prior treatment must have had that toxicity recovered to grade 1 or lower, with the exception of alopecia. Participants additionally need to have adequate hematopoietic, hepatic, and renal function.
Patients who have had chemotherapy, live vaccines, another investigational therapy, major surgery (excepting that for vascular access placement), infection requiring systemic treatment, or checkpoint inhibitor therapy in the 30 days before Day 1 will be excluded from participation. Additional exclusion criteria apply to patients with active autoimmune disease requiring immunosuppressive therapy; a history of peritoneal effusion, pericardial, pleural effusions/nodules, arrhythmia including atrial fibrillation; uncontrolled hypertension, unstable angina, decompensated congestive heart failure, a cardiac ejection fraction of less than or equal to 50%, myocardial infarction, marked baseline prolonged QT/QTc intervals; or detection of HIV, hepatitis B, or hepatitis C. Patients who participated in the treatment portion of a clinical trial or completed a clinical trial in the 30 days before the first dose of Deltacel are also excluded.
Deltacel is non-engineered and based on a platform that aims to utilize the natural characteristics of GDTs in the targeting of solid cancers; as such, viral vectors are not required in the manufacturing process.2 Notably, earlier this month, the therapy, as used in combination with LDRT, received fast track designation from the FDA for metastatic NSCLC in patients who have progressed on 2 or more lines of standard of care therapy, including platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy to improve PFS and OS.3
“Receipt of Fast Track designation is a significant milestone for Kiromic and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors,” Bersani said in a statement.3 “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track designation will enable us to work more closely with the FDA as we complete Deltacel-01 and advance this promising therapy into later stage studies.”
REFERENCES
1. Kiromic Biopharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed August 12, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-provides-update-part-1-deltacel-01-trial
2. Kiromic BioPharma to advance Deltacel-01 clinical trial to part 2, expansion phase. News release. Kiromic BioPharma, Inc. July 18, 2024. Accessed August 19, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-advance-deltacel-01-clinical-trial-part-2
3. Kiromic BioPharma’s Deltacel receives FDA fast track designation. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed August 19, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharmas-deltacel-receives-fda-fast-track-designation
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