Actively Recruiting
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
Led by Suzhou Forlong Biotechnology Co., Ltd · Updated on 2025-08-14
80
Participants Needed
12
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG. To evaluate the preliminary efficacy of FL115 alone or in combination with BCG in the treatment of NMIBC. The study consists of three parts: FL115 monotherapy dose escalation (Phase Ia), FL115 combined with BCG dose escalation (Phase Ib), and FL115 combined with BCG cohort expansion (Phase II). Each subject will receive FL115 alone or in combination with intravesical BCG, administered over three treatment periods: induction, enhanced induction/maintenance 1, and maintenance 2.
CONDITIONS
Official Title
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Histologic confirmation of non-muscle invasive bladder cancer with high-grade transitional cell carcinoma
- Presence of BCG-unresponsive carcinoma in situ or high-grade Ta or T1 disease confirmed by biopsy
- No resectable disease after transurethral resection, with repeat resection if needed for T1 tumors
- Subjects refuse or are unsuitable for radical cystectomy
- ECOG performance status score between 0 and 2
- Expected survival of at least 2 years
- Adequate organ function
- Provide voluntary written informed consent and agree to follow study procedures and evaluations
You will not qualify if you...
- Previous IL-2 or IL-15 agonist therapy including rhIL-15, ALT-803 (FL-115), or NKTR-214
- Extensive pelvic radiotherapy involving more than 30% of bone marrow within 2 years
- Systemic therapy for NMIBC within 4 weeks prior to first dose
- Intravesical treatment for NMIBC within 4 weeks prior to first dose
- TURBT or bladder surgery within 2 weeks prior to first dose
- Allergy to FL115, interleukin-based therapies, fusion proteins, or BCG for relevant phases
- Recent systemic immunosuppressive therapy within 4 weeks, except certain low-dose steroids
- Prior allogeneic organ or bone marrow transplantation
- Live virus vaccination within 4 weeks before first dose
- Severe immune-related adverse events from prior immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin reactions
- Unresolved adverse events from prior anti-tumor therapy not returned to baseline except specified exceptions
- Muscle-invasive, locally advanced, or metastatic bladder cancer history or diagnosis
- Tumors in upper urinary tract or prostatic urethra
- Vesicoureteral reflux or bladder perforation
- Active urinary tract infection
- Severe adverse reactions leading to BCG therapy discontinuation
- Post-surgical complications preventing intravesical treatment
- Clinically significant polyuria
- Other malignancies within 2 years with progression or requiring treatment
- Active or prior autoimmune disease needing systemic immunosuppressants
- History of severe lung toxicity or active tuberculosis
- Uncontrolled significant fluid collections like pleural or pericardial effusion
- Significant cardiovascular disease
- Major surgery within 4 weeks before consent
- Severe infections within 4 weeks before first dose
- Active HBV, HCV, HIV, or active tuberculosis infection
- Pregnant or breastfeeding women
- Known or suspected substance abuse except medically justified opioid use
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
4
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Fujian, China, 325000
Actively Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410030
Actively Recruiting
6
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
7
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
8
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
9
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
10
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
11
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
12
Fudan University Cancer Hospital
Shanghai, China, 200000
Actively Recruiting
Research Team
X
Xuxiajun Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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