Deltacel (KB-GDT-01) / Kiromic - LARVOL DELTA

DELTACEL-01: Safety Study for a Gamma Delta T Cell Product Used with Low Dose Radiotherapy in Patients with Locally Advanced or Metastatic NSCLC or Solid Tumors with Bone Metastases (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Kiromic BioPharma Inc. | Trial completion date: Jan 2027 ➔ Oct 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • ROS1

Kiromic BioPharma Reports Patient 4 in Deltacel-01 Clinical Trial Reaches 10-Month Progression-Free Survival (Businesswire) - P1 | N=48 | DELTACEL-01 (NCT06069570) | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma...reports continued favorable efficacy results from the 10-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial and provides an enrollment update. This trial is evaluating Deltacel (KB-GDT-01)...in patients with stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies. The fourth patient in Deltacel-01 demonstrated a partial response (defined as a 30% or greater decrease in the size of the tumor) at the eight-month follow-up visit and continued without any evidence of disease progression as of the 10-month follow-up visit, thereby extending progression-free survival (PFS) to 10 months....Additionally, Kiromic reports that two subjects are undergoing screening and are scheduled to start treatment at Texas Oncology in Tyler, Texas, in late February and early March, respectively."

P1 data • Trial status • Non Small Cell Lung Cancer

The Eighth Patient Completes Treatment (Businesswire) - "The eighth patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in late February 2025. This patient was enrolled at the Clinical Research Advisors Koreatown, a satellite location of BHCC....Kiromic also announces that the ninth patient in Deltacel-01 started treatment at Virginia Oncology Associates (Norfolk, VA). Additionally, the company expects to enroll the 10th and 11th patients into the trial by the end of January."

Enrollment status • P1 data • Non Small Cell Lung Cancer

Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01 (Businesswire) - P1 | N=48 | DELTACEL-01 (NCT06069570) | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable efficacy results from the 12-month follow-up visit for the first patient and the two-month follow-up visit for the seventh patient enrolled in its Deltacel-01 Phase 1 clinical trial....At the 12-month post-treatment follow-up visit, the first patient in Deltacel-01 had a 33.33% reduction in tumor volume compared with their pre-treatment tumor size, thereby achieving a partial response. This marks the second patient in the Deltacel-01 study with a partial response after our fourth patient. Additionally, the seventh patient had a 9.5% reduction in tumor size at their two-month follow-up visit. Both patients are being treated at the Beverly Hills Cancer Center (BHCC)."

P1 data • Non Small Cell Lung Cancer

Kiromic BioPharma Reports 32% Decrease in Tumor Volume Eight Months Post-Treatment in Fourth Patient Enrolled in Deltacel-01 (Businesswire) - P1 | N=48 | DELTACEL-01 (NCT06069570) | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable ongoing efficacy results from the eight-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides additional updates on the first and seventh patients...Preliminary results from the eight-month follow-up visit for the fourth patient enrolled in Deltacel-01 revealed an approximately 32% decrease in tumor volume compared with the pre-treatment size...The first patient enrolled in the Deltacel-01 trial has maintained stable disease with no evidence of disease progression or new sites of malignancy. Kiromic last reported that in this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size...The seventh patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in early January 2025."

P1 data • Non Small Cell Lung Cancer

Kiromic BioPharma Reports Favorable Ongoing Clinical Results From Fourth and Sixth Patients Enrolled in Deltacel-01 (Businesswire) - P1 | N=48 | DELTACEL-01 (NCT06069570) | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable ongoing efficacy results from follow-up visits for Patient 4 and Patient 6 in its Deltacel-01 Phase 1 clinical trial....At the six-month follow-up visit, Patient 4 maintained stable disease with a 5.3% reduction in tumor size compared to the pre-treatment size. At the two-month follow-up visit, Patient 6 demonstrated stable disease with no new lesions detected and no signs of disease progression....As a result of these updates, the median progression-free survival (PFS) across the trial has now increased to 6 months, highlighting the potential of Deltacel-01 to delay disease progression in advanced lung cancer patients. The median follow-up duration for all patients in the trial is now 7.7 months."

P1 data • Non Small Cell Lung Cancer

Kiromic BioPharma Reports Favorable 10-Month Follow-Up Results for the First Patient Treated in its Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | Deltacel-01 (NCT06069570) | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports good safety and favorable ongoing efficacy results from the 10-month follow-up visit of the first patient treated in its Deltacel-01 Phase 1 clinical trial....In this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size, and no new sites of disease were identified. As a result, the progression-free survival (PFS) has reached 10 months with no reported adverse events. These results follow an approximate 20% reduction in tumor size detected at eight months post-treatment and an approximate 13% reduction at six months post-treatment....Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October."

P1 data • Non Small Cell Lung Cancer

Kiromic BioPharma Advances Deltacel-01 Into Expansion Phase Following Safety Monitoring Committee’s Unanimous Recommendation (Businesswire) - "Kiromic BioPharma, Inc...announced today that the Deltacel-01 Safety Monitoring Committee (SMC) has unanimously voted in favor of proceeding with the expansion phase of the Deltacel-01 clinical trial. This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies...As part of the expansion phase of Deltacel-01, Kiromic will enroll approximately nine patients. Screening for new participants is expected to commence later this month. The expansion phase, or Part 2 of Deltacel-01, will further assess the effectiveness of Deltacel treatment."

DSMB • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Activates the University of Arizona Cancer Center as the Fifth Clinical Trial Site in the Ongoing Phase 1 Deltacel-01 Trial (Businesswire) - "Kiromic BioPharma...announces that the University of Arizona Cancer Center (UACC) has been activated as the fifth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies....The site initiation visit at UACC has been completed and patient enrollment is expected to begin in the coming weeks."

Trial status • Non Small Cell Lung Cancer

Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation (Businesswire) - "Kiromic BioPharma, Inc...announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least two lines of standard of care therapy including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapy to improve progression-free survival and overall survival. Deltacel is currently being evaluated in the Deltacel-01 Phase 1 study in patients with stage 4 NSCLC who have failed to respond to standard therapies....Kiromic expects to activate a fifth clinical trial site on August 30th."

Fast track • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Provides Update on Part 1 of the Deltacel-01 Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports interim results near the completion of Part 1 of its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies. Based on data from the five patients evaluated for Progression-Free Survival (PFS) in the long-term follow-up, Kiromic has registered a PFS ranging from 2 to 8 months, with an average of 4.8 months....Additionally, the sixth and last patient in Part 1 of the Deltacel-01 study started treatment on August 6th....Kiromic is on track to initiate Part 2 of Deltacel-01 in September."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports 20% Tumor Size Reduction at Eight Months in First Patient Enrolled in Deltacel-01 (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable eight-month follow-up results from the first patient enrolled in its Deltacel-01 Phase 1 clinical trial...Scans taken eight months post-treatment showed the patient’s tumor size had decreased by 20% compared with the pre-treatment size and no new tumor lesions were detected, which indicate an eight-month progression-free survival. This follows a 13% reduction detected at six months post-treatment, showing a continued favorable progression...Kiromic expects to report additional follow-up results from the fourth and fifth patients in the study in August."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma to Advance Deltacel-01 Clinical Trial to Part 2, Expansion Phase (Businesswire) - "Kiromic BioPharma...announces plans to advance the Deltacel-01 Phase 1 clinical trial to the Expansion Phase following a positive assessment from the Deltacel-01 Safety Monitoring Committee (SMC). The SMC convened on July 16th and reviewed safety and efficacy data collected to-date in Deltacel-01, confirming favorable results and optimal dose....Following approval by the SMC, Part 2 (the Expansion Phase) will then further assess the therapy’s effectiveness at the optimal dose identified in Part 1. Kiromic plans to begin enrolling patients in the Expansion Phase in September, expanding the size of the trial by nine patients....Additionally, the fifth patient in Deltacel-01 completed their 30-day visit, with a favorable safety profile and no dose-limiting toxicities reported. Kiromic expects to report early efficacy data from this patient’s two-month follow-up in August."

DSMB • P1 data • Trial status • Non Small Cell Lung Cancer

Kiromic BioPharma Provides Updates on its Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "The third and fourth patients showed stable disease at their four- and two-month follow-up visits, respectively. Both patients are doing well, and neither showed any dose-limiting toxicities...The second patient...previously had stable disease and showed a complete response in their brain metastasis...Kiromic BioPharma also reports submitting a request for Fast Track designation for Deltacel to the FDA...The fifth patient in the trial completed their 30-day safety visit at the BHCC with no toxicities reported, and the sixth patient is expected to be enrolled in July...FDA and IRB Approve IND for a Single-Use, Single-Patient Treatment with Deltacel..."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Six-Month Results from First Patient Enrolled in Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma...reports favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel (KB-GDT-01)...Scans taken six months post-treatment showed the patient’s tumor size had decreased by 13% compared with the pre-treatment size, and no new tumor lesions were detected, which translates into a six-month progression-free survival. In addition, no dose-limiting toxicities were reported...Kiromic continues to expect to report long-term follow-up results for the other two subjects in the first cohort and the first subject in the second cohort by the end of June...Additionally, the fifth patient....is currently doing well without any signs of toxicity and is expected to have their first efficacy assessment in July. The sixth patient is currently undergoing pre-enrollment screening and is projected to start treatment in mid-June."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Favorable Results at Six Weeks from Fourth Patient in Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Preliminary results of this first patient in the second cohort obtained six weeks after beginning treatment show a favorable safety and tolerability profile, while imaging shows promising early efficacy for the Deltacel treatment. Scans showed disease stabilization, no new sites of metastatic disease and an 8.5% reduction in the tumor size. Additionally, this patient experienced quality-of-life benefits from Deltacel treatment including stopping their previous need for prescription pain medication....The six-week follow-up visit revealed stable disease, no new lesions and an 8.5% reduction in tumor size compared with pre-treatment measurements."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Adds UPMC as Fourth Deltacel-01 Clinical Trial Site (Businesswire) - "Kiromic BioPharma...announces that UPMC in Pittsburgh, Pennsylvania has been activated as the fourth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC)....Kiromic also announces favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01, with early efficacy data on this patient expected by the end of May. The fifth and sixth patients are expected to be enrolled later in May and June, respectively."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...announces consistent favorable safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC)....Two months after completing treatment, Patients 2 and 3 continued to show stable disease. Imaging scans from Patient 2 also showed no brain metastases, confirming findings from that patient’s six-week follow-up visit....Based on encouraging preliminary results from the first patient cohort, Kiromic intends to apply for Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) by the end of the second quarter."

Fast track designation • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial....Preliminary imaging results for this last patient in the first cohort, obtained six weeks after beginning treatment, show a favorable safety and tolerability profile, and promising early efficacy for the Deltacel treatment....After reviewing safety and efficacy findings from the first cohort of three patients, the SMC recommended not to escalate the cell dose level and instead to treat the next cohort of patients at the initial dose level. This unanimous recommendation was based on encouraging preliminary data supporting Deltacel safety and tolerability, and evidence of anti-tumor activity."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Early Efficacy Results Show Primary Lung Tumor Stabilization and Complete Disappearance of Brain Metastases in Second Patient in Kiromic BioPharma’s Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports early efficacy results showing primary lung tumor stabilization and the complete disappearance of brain metastases in the second patient in the Company’s Deltacel-01 Phase 1 clinical trial....Preliminary results obtained six weeks from the beginning of treatment show Deltacel’s efficacy in controlling tumor growth, as well as favorable safety and tolerability. Stable disease status was confirmed by CT scan....Kiromic expects to announce initial safety, tolerability, and preliminary efficacy results from the third patient enrolled in Deltacel-01 by the end of March."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Adds Virginia Oncology Associates, PC as the Second Clinical Trial Site in the Ongoing Phase 1 Deltacel-01 Trial (Businesswire) - "Kiromic BioPharma, Inc...announces that Virginia Oncology Associates, PC (Norfolk, Virginia) has been activated as the second clinical trial site in the Phase 1 Deltacel-01 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with non-small cell lung cancer (NSCLC)...The site initiation process at Virginia Oncology Associates has been completed and patient enrollment is expected to begin in April, following receipt of preliminary results from the first three-patient cohort in Deltacel-01....Kiromic expects to announce initial safety and tolerability data, as well as preliminary efficacy results, from this patient and from the trial’s second patient by the end of March."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Results from First Patient in Kiromic BioPharma’s Deltacel-01 Clinical Trial Indicate Tumor Reduction at Two Months (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...announces continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company’s Phase 1 clinical trial evaluating Deltacel™ for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC). After stable disease and preliminary progression-free survival of one and a half months were reported six weeks post-treatment, the two-month follow-up PET/CT scan revealed that the patient’s tumor size was reduced by 6.6%, and no new disease sites (metastasis) were detected. In addition, a 20% decrease in the tumor lesion’s metabolism was noted."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Favorable Early Efficacy Results from First Patient in Deltacel-01 Phase 1 Clinical Trial in Non-Small Cell Lung Cancer (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel for treating stage 4 metastatic non-small cell lung cancer (NSCLC)...Favorable preliminary evidence demonstrates Deltacel’s efficacy in controlling the growth of NSCLC. Deltacel continues to be well-tolerated....The CT scan performed six weeks later confirmed stabilization of the disease, indicating a preliminary progression-free survival of one and one-half months. Kiromic plans to provide updates as more data becomes available from follow-up monitoring activities and as additional subjects are enrolled in the study."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kiromic BioPharma Reports Favorable Early Safety and Tolerability Data from First Patient Enrolled in the Phase 1 Deltacel-01 Clinical Trial (Businesswire) - P1 | N=48 | NCT06069570 | Sponsor: Kiromic BioPharma Inc. | "Kiromic BioPharma, Inc...reports favorable safety and tolerability from the first patient 23 days after Deltacel™ infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA. Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile. Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients....Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024."

Enrollment status • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Kiromic BioPharma Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • ROS1