Clinical trials: BCG
Tuberculosis
Clinical Study of BCG Vaccine for Intradermal Injection
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design. In this trial, 160 subjects were enrolled.
- Trial name
- NCT04563273
- Testing
- BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person）, BCG vaccine 3（0.075mg/0.1ml/person）
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Non-muscle-invasive Bladder Cancer
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.
- Trial name
- NCT05710848
- Testing
- STM-416
- Where
- 20 sites in United States
- Volunteers
- 75 people
- Sponsor
- SURGE Therapeutics
NMIBC
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with…
- Trial name
- NCT07424287
- Testing
- SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Non Muscle Invasive Bladder Cancer, Bladder Cancer
Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients
This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are…
- Conditions
- Non Muscle Invasive Bladder Cancer, Bladder Cancer, Carcinoma in Situ of Bladder, Urinary Bladder Neoplasms
- Trial name
- HIVEC (NCT07231809)
- Testing
- Hyperthermic Intravesical Chemotherapy (HIVEC)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- AC.TA. S.r.l.
Pharmacokinetics
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
- Trial name
- NCT04142359
- Testing
- BCG in Combination with N-803, N-803 alone
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Altor BioScience
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
NMIBC
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus…
- Trial name
- NCT06800963
- Testing
- Intravesical Recombinant Mycobacterium (rMBCG)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Non-muscle Invasive Bladder Cancer (NMIBC)
Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose…
- Trial name
- NCT03719300
- Testing
- inodiftagene vixteplasmid
- Where
- 48 sites in United States
- Volunteers
- 32 people
- Sponsor
- Anchiano Therapeutics Israel Ltd.
Nonmuscle-invasive Bladder Cancer
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
- Trial name
- NCT06971614
- Testing
- T3011
- Where
- 9 sites in United States
- Volunteers
- 160 people
- Sponsor
- ImmVira Pharma Co. Ltd
Bladder Cancer
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy.
- Trial name
- VISTA (NCT02449239)
- Testing
- Vicinium
- Where
- 70 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Sesen Bio, Inc.
Bladder Carcinoma in Situ (CIS)
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or…
- Trial name
- NCT05024773
- Testing
- ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
- Where
- 47 sites in United States, France and 4 more
- Volunteers
- 130 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Bladder Cancer
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
- Trial name
- NCT01284205
- Testing
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Where
- 14 sites in United States
- Sponsor
- Bioniche Life Sciences Inc.
High-risk Non-muscle Invasive Bladder Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the…
- Trial name
- NCT03711032
- Testing
- Pembrolizumab, BCG
- Where
- 209 sites in United States, Australia and 28 more
- Volunteers
- 1,397 people
- Sponsor
- Merck Sharp & Dohme LLC
Cutaneous Melanoma
Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients
Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB…
- Trial name
- NCT01729663
- Testing
- CSF470 vaccine, BCG, Molgramostim, interferon alpha 2b
- Where
- Argentina
- Volunteers
- 108 people
- Sponsor
- Laboratorio Pablo Cassara S.R.L.
NMIBC
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1…
- Trial name
- NCT07551544
- Testing
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Sponsor
- ImmunityBio, Inc.
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Bladder Cancer, High Grade
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1…
- Conditions
- Bladder Cancer, High Grade, Non Muscle Invasive
- Trial name
- exBOND (NCT02143804)
- Testing
- oncolytic adenovirus expressing GMCSF
- Where
- United States
- Sponsor
- CG Oncology, Inc.
Non-muscular Invasive Bladder Cancer
Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)
- Trial name
- NCT06350838
- Testing
- BCG for Therapeutic Use
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Bladder Cancer, Bladder Cancer Recurrent
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE…
- Conditions
- Bladder Cancer, Bladder Cancer Recurrent, Neoplasm Recurrence, Urothelial Carcinoma Bladder
- Trial name
- EVER (NCT05037279)
- Testing
- Bacillus Calmette-Guerin: Strain Russian BCG-I, Bacillus Calmette-Guerin: Strain TICE
- Where
- 6 sites in Canada
- Volunteers
- 540 people
- Sponsor
- Verity Pharmaceuticals Inc.