Non-muscle Invasive Bladder Cancer (NMIBC)Phase 1/2NCT07122414
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
A Phase 1/2 study testing FL115 and FL115+BCG in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Suzhou Forlong Biotechnology Co., Ltd at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- FL115 and FL115+BCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesChina
- Study dates
- 16 Aug 2024to 10 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older.
- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
- Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.
- Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
- Subjects refuse or are judged by the investigator not suitable for radical cystectomy.
- ECOG score 0-2.
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- Expected survival ≥ 2 years (judged by the investigator).
- Adequate organ function.
- Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.
Who cannot join
- 1.Prior Anti-Cancer Treatment History:
- Have previously received IL-2 or IL-15 agonist therapy, including but not limited to rhIL-15 (NCI), ALT-803 (FL-115), and NKTR-214 (Nektar).
- Have previously undergone any of the following NMIBC-related treatments:
- Received extensive pelvic radiotherapy (involving >30% of bone marrow) within 2 years prior to the first dose.
- Received systemic therapy aimed at treating NMIBC (e.g., radiotherapy, chemotherapy, immunosuppressive therapy) within 4 weeks prior to the first dose.
- Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered transurethrally.
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- Underwent TURBT or other surgical procedures targeting bladder lesions within 2 weeks prior to the first dose.
- 2. Prior therapies and recovery from related toxicities：
- Known or suspected allergy to FL115, its excipients, interleukin-based therapies, or fusion proteins (Grade 3-4), or to BCG/excipients (for Phase Ib/II).
- Systemic immunosuppressive therapy within 4 weeks before first dose, except: ≤10 mg/day prednisone equivalent, local/inhaled/intranasal steroids, adrenal replacement ≤7.5 mg/day prednisone, or single-dose prophylaxis for contrast allergy.
- Prior allogeneic organ or PBSC/bone marrow transplantation. d) Live virus vaccination within 4 weeks prior to first dose. e) Prior ≥ Grade 3 or treatment-discontinuation irAE due to immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin irAEs.
- Unresolved AEs from prior anti-tumor therapy that have not returned to baseline or ≤ Grade 1 (per CTCAE v5.0) prior to first dose, except alopecia, ≤ Grade 2 neuropathy, or controlled hypothyroidism. Other ≤ Grade 2 AEs require PI and sponsor medical review.
- 3.Medical and Surgical History:
- History or current diagnosis of muscle-invasive (T2-T4), locally advanced (T3/T4, any N), or metastatic bladder cancer.
- History or evidence of upper urinary tract (kidney, renal pelvis, ureter) or prostatic urethral tumors.
- Known vesicoureteral reflux or evidence of bladder perforation.
- Active urinary tract infection.
- Discontinuation of prior BCG therapy due to severe adverse events such as sepsis, systemic infection requiring treatment, or urinary incontinence (Phase Ib and II applicable).
- Post-TURBT complications that preclude intravesical instillation, per investigator judgment.
- Clinically significant polyuria (e.g., 24-hour urine volume >4000 mL).
- History of other malignancies within 2 years prior to screening that have shown progression or required active treatment.
- Active or prior autoimmune disease requiring systemic immunosuppressants or corticosteroids.
- History of severe pulmonary toxicity.
- History or imaging evidence of active pulmonary TB within 1 year prior to enrollment, or prior TB infection not adequately treated.
- Uncontrolled pleural, pericardial, or peritoneal effusion deemed clinically significant by the investigator (e.g., requiring repeated drainage >once/month).
- History of significant cardiovascular disease.
- Major surgery within 4 weeks prior to signing informed consent.
- 4.Infectious Disease History
- Severe infections within 4 weeks before first dose. b) Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection.
- 5.Other Conditions
- Pregnant or breastfeeding women.
- Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).
- Any other conditions deemed by the investigator to render the subject unsuitable for participation.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yangyong, yoya_urology@sina.com
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhangshudong, shootong@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410030
Jiangshusuan, jiangshusuan@hnca.org.cn
- Recruiting
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Liujing, 020810908@163.com
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Xuning, drxun@163.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Guohongqian, gymwgcp@126.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Niuhaitao, niuht0532@126.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Caoyu, Caoyu1767@126.com
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200000
Yedingwei, dwyeli@163.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Xueboxin, 18994392817@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Huhailong, hhllove2004@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Fujian, 325000
Huanghang, Huanghang163@163.com
About this study
Official title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion
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.
- Being tested
- FL115, FL115+BCG
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL115Drug
FL115 single agent dose escalation,
FL115+BCGDrug
FL115 in combination with BCG
| Study group | Role | What they receive |
|---|---|---|
| FL115 and BCG | Experimental | Not described Receives: Drug: FL115; Drug: FL115+BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximal Tolerance Dose
Measured: up to 15 months
RP2D
Recommended Phase II Dose
Measured: up to 15 months
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, up to 5 years
Complete Response
Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
Measured: 36 months
Disease-Free Rate
Assess disease-free rate at 12 months since first study treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start16 Aug 2024
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Forlong Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122414
- Sponsor's protocol ID
- FL115-103
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our research is based on earlier studies and there is a high degree of uncertainty. We will consider sharing the results only after we have obtained sufficient data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion
- ClinicalTrials.gov ID
- NCT07122414
- Acronym / sponsor ID
- FL115-103
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Suzhou Forlong Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FL115 and BCG | Experimental | Drug: FL115, Drug: FL115+BCG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects aged 18 years or older.
- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
- Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.
- Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
- Subjects refuse or are judged by the investigator not suitable for radical cystectomy.
Key exclusion criteria (33 listed)
- Have previously received IL-2 or IL-15 agonist therapy, including but not limited to rhIL-15 (NCI), ALT-803 (FL-115), and NKTR-214 (Nektar).
- Have previously undergone any of the following NMIBC-related treatments:
- 2. Prior therapies and recovery from related toxicities：
- Known or suspected allergy to FL115, its excipients, interleukin-based therapies, or fusion proteins (Grade 3-4), or to BCG/excipients (for Phase Ib/II).
- Systemic immunosuppressive therapy within 4 weeks before first dose, except: ≤10 mg/day prednisone equivalent, local/inhaled/intranasal steroids, adrenal replacement ≤7.5 mg/day prednisone, or single-dose prophylaxis for contrast allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL115FL115 single agent dose escalation, | Drug | FL115 and BCG |
| FL115+BCGFL115 in combination with BCG | Drug | FL115 and BCG |
Primary outcome
MTD
Time frame: up to 15 months
Maximal Tolerance Dose
RP2D
Time frame: up to 15 months
Recommended Phase II Dose
Safety and tolerability
Time frame: through study completion, up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Complete Response
Time frame: 36 months
Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
Disease-Free Rate
Time frame: 12 months
Assess disease-free rate at 12 months since first study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Our research is based on earlier studies and there is a high degree of uncertainty. We will consider sharing the results only after we have obtained sufficient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FL115 and FL115+BCG in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Suzhou Forlong Biotechnology Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuxiajun Medical Director (+86-18101882657, xiajunxu@forlongbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: up to 15 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.