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Antisense Oligonucleotide

BP1002 for Lymphoma

Phase 1
Recruiting
Research Sponsored by Bio-Path Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study
Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2
Must not have
Females who are pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug
Uncontrolled active, untreated, or progressive infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 210 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug for patients with advanced lymphoma who have relapsed or are resistant to treatment. Up to 12 patients will be given the drug and monitored for safety and effectiveness.

Who is the study for?
Adults over 18 with advanced lymphoid malignancies that have not responded to or returned after treatment, including various types of lymphoma and leukemia. Participants must be expected to live at least 3 months, have good liver and kidney function, and use contraception if applicable. They should not be eligible for certain other cancer treatments.
What is being tested?
The trial is testing BP1002 (L-Bcl-2 antisense oligonucleotide) for safety, how the body processes it, and its effectiveness in treating patients with relapsed or refractory lymphoid malignancies. Up to 12 patients will receive this experimental therapy.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with antisense oligonucleotides such as injection site reactions, flu-like symptoms, fatigue, fever, nausea and potential liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot become pregnant, am surgically sterile, postmenopausal, or use reliable birth control.
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I can take care of myself and am up and about more than half of my waking hours.
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My lymphoma came back or didn't fully respond to treatment.
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I've tried or can't use standard treatments, including stem cell transplant and CAR T-cell therapy.
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My liver and kidney tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor plan to become pregnant or breastfeed during the study.
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I do not have any untreated or uncontrolled infections.
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I am able and willing to follow study instructions and communicate with the research team.
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I haven't received any cancer treatment in the last 14 days.
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I am eligible for high dose chemotherapy and a stem cell transplant using my own cells.
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I have not had a heart attack, stroke, or similar event in the last 6 months.
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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine half-life plasma pharmacokinetics (PK) of BP1002
Determine pharmacokinetics (PK) of BP1002
Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant
+7 more
Secondary study objectives
Activity of BP1002 on Bcl-2 expression in tumor samples
Determine estimates for event-free survival (EFS)
Determine estimates for progression-free survival (PFS)
+3 more
Other study objectives
Exploratory objective to correlate treatment response with cytogenetic characteristics
Exploratory objective to correlate treatment response with molecular characteristics

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BP1002 monotherapyExperimental Treatment1 Intervention
L-Bcl-2 Antisense oligonucleotide (BP1002) is given in a sequential, dose escalation design. Starting dose is 20mg/m\^2.

Find a Location

Who is running the clinical trial?

Bio-Path Holdings, Inc.Lead Sponsor
5 Previous Clinical Trials
266 Total Patients Enrolled

Media Library

L-Bcl-2 antisense oligonucleotide (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04072458 — Phase 1
Waldenstrom Macroglobulinemia Research Study Groups: BP1002 monotherapy
Waldenstrom Macroglobulinemia Clinical Trial 2023: L-Bcl-2 antisense oligonucleotide Highlights & Side Effects. Trial Name: NCT04072458 — Phase 1
L-Bcl-2 antisense oligonucleotide (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04072458 — Phase 1
~6 spots leftby Dec 2025
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