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CAR T-cell Therapy

CB307 for Solid Tumors (POTENTIA Trial)

Phase 1
Recruiting
Research Sponsored by Crescendo Biologics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS <=2
Aged at least 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up progression-free survival according to recist v1.1 or pcwg3 up to 20 months duration; and change from baseline in anti-drug (cb307) antibodies (ada up to 20 months duration
Awards & highlights

POTENTIA Trial Summary

This trial tests a new medicine to treat advanced and metastatic tumors, looking at safety, tolerability, and dosage.

Who is the study for?
This trial is for adults with advanced or metastatic PSMA+ solid tumors who can't be helped by standard treatments. They must understand the consent form, have a performance status indicating they are relatively active, and their organs must function well. People with autoimmune diseases, brain metastases, active infections, CNS disease history, or those intolerant to certain immunotherapies cannot join.Check my eligibility
What is being tested?
The study tests CB307 alone and in combination with pembrolizumab (KEYTRUDA®) on patients with specific advanced cancers that express PSMA. It's an early-phase trial to find out the maximum dose people can take without serious side effects and to see how effective these treatments might be.See study design
What are the potential side effects?
Potential side effects of CB307 and pembrolizumab may include immune system reactions affecting various organs, infusion-related responses like fever or chills, fatigue, possible digestive issues such as nausea or diarrhea, skin reactions like rash or itching.

POTENTIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My cancer is advanced, spreads to other parts, and tests positive for PSMA.
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My cancer can be measured by scans or blood tests.

POTENTIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~progression-free survival according to recist v1.1 or pcwg3 up to 20 months duration; and change from baseline in anti-drug (cb307) antibodies (ada up to 20 months duration
This trial's timeline: 3 weeks for screening, Varies for treatment, and progression-free survival according to recist v1.1 or pcwg3 up to 20 months duration; and change from baseline in anti-drug (cb307) antibodies (ada up to 20 months duration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events with CB307 in combination with pembrolizumab as assessed by CTCAE v5.0
Secondary outcome measures
Pharmacokinetic of CB307 T1/2
Pharmacokinetic of CB307 Tmax
Relationship of CB307 to anti tumour response
+5 more

POTENTIA Trial Design

2Treatment groups
Experimental Treatment
Group I: Multi center open label Dose Escalation followed by Combination Cohort Expansion : Part 2BExperimental Treatment1 Intervention
Patients will receive CB307 IV infused every 7 days in combination with KEYTRUDA® (pembrolizumab) IV infused every 21 days . Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2B arm will enrol patients with PSMA+ metastatic castration-resistant prostate cancer. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months.
Group II: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2AExperimental Treatment1 Intervention
Patients will receive CB307 IV infused every 7 days. Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2A arm will enrol patients with PSMA+ solid tumours. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months.

Find a Location

Who is running the clinical trial?

Crescendo Biologics Ltd.Lead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
J TilsonStudy DirectorCrescendo Biologics
S RajballyStudy DirectorCrescendo Biiologics

Media Library

CB307 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04839991 — Phase 1
Solid Tumors Research Study Groups: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A, Multi center open label Dose Escalation followed by Combination Cohort Expansion : Part 2B
Solid Tumors Clinical Trial 2023: CB307 Highlights & Side Effects. Trial Name: NCT04839991 — Phase 1
CB307 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839991 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ample research sites carrying out the clinical trial in this urban environment?

"This trial is currently available at 20 separate locations, situated in Seattle, Barcelona and Madrid among others. To reduce the travel burden for participants, it's essential to select a clinic as close as possible to your location when signing up."

Answered by AI

Is there an ongoing call for participants to join the experiment?

"Affirmative, the information on clinicaltrials.gov indicates that this trial is actively looking for participants. It was initially published on June 8th 2021 and most recently updated July 20th of this year. 70 individuals need to be enrolled across 20 different medical sites."

Answered by AI

How many individuals are being recruited for this clinical study?

"This trial mandates the inclusion of 70 patients with suitable prerequisites. Potential participants can pursue involvement in this research at University of Washington (Seattle, WA) or hospital clinic de Barcelona (Barcelona, Navarra)."

Answered by AI

Has the FDA accepted the Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A protocol?

"Our team at Power assess the safety of this Phase 1 trial to be a 1, due to limited evidence supporting its efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
2021. "Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04839991.
~4 spots leftby Jul 2024
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