Recent Updates
Recently added Catalysts

KB-GDT-01

Phase 2

Carcinoma, Non-Small-Cell Lung Cancer | Biologics | Oncology |Kiromic BioPharma, Inc.|Trials Updated: Mar 5, 2025

KB-GDT-01 development status

Highest phase Phase 2 run by West China Hospital (NCT07040956)
Phase scored for KRBPQPhase 1
Registered trials 2 across 2 sponsors since Oct 2023

KB-GDT-01 target and mechanism

ModalityBiologics

Also known as Low dose radiotherapy

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

KB-GDT-01 clinical trials

KB-GDT-01 · 1 trial · 2 indications

Phase 1 1
NCT06069570Safety 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 MetastasesCarcinoma, Non-Small-Cell Lung Cancer
RECRUITING48 Analytics
PHASE1RECRUITING
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
Carcinoma, Non-Small-Cell Lung Cancer
NCT0606957048
Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later

DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.

Secondary Endpoints

Objective Response Rate (ORR)
From first study drug infusion through to Month 24
Progression Free Survival (PFS)
From first study drug infusion until the first evidence of disease progression, death or Month 24.
Overall Survival (OS)
From first study drug infusion until death or Month 24.
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KB-GDT-01 cellsEXPERIMENTALDose Level 1: 400 x10\^6, 800 x10\^6 or 1600 x10\^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction)

Interventions

NameTypeDescription
KB-GDT-01BIOLOGICALKB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells/bag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy/fraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Signed and dated informed consent form. * Male or female, \> 18 years old. * Minimum body weight of 50 kilograms (kg). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC or loc...

Countries:United States
Unlock Eligibility Criteria

Explore more on BiopharmaWatch

Kiromic BioPharma, Inc. (KRBPQ)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with KCompanies A to ZEvery biotech and pharma company we track