BridgeMD
New treatment option for T-cell Lymphoma
Official title CD4CAR for CD4+ Leukemia and Lymphoma
ClinicalTrials.gov ID: NCT03829540
What this study is testing
What is CD4CAR?
CD4CAR is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:
- Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability...
- Age 12 years old or older
- people with any documented CD4+ T cell hematologic malignancies. Male and female people with CD4+ T-cell hematologic malignancies with either...
- Creatinine clearance of \> 60 ml/min (or otherwise non clinically-significant, per study investigator)
You likely can't join if
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see...
- Uncontrolled active infection necessitating systemic therapy.
- Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results...
- people with a history of hepatitis B but have received antiviral therapy and have nondetectable viral DNA for 6 months prior to enrollment are...
- people seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are...
- people who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible
See the full eligibility criteria
Who can join
- In order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:
- Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability for the duration of the study.
- Age 12 years old or older
- people with any documented CD4+ T cell hematologic malignancies. Male and female people with CD4+ T-cell hematologic malignancies with either relapsed or refractory disease (including those patients who have undergone a...
- Creatinine clearance of \> 60 ml/min (or otherwise non clinically-significant, per study investigator)
- ALT/AST \< 3 x ULN
- Bilirubin \< 2 x ULN
- No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion
- Adequate cardiac function with EF of ≥50%
- Adequate venous access for apheresis and no other contraindications for leukapheresis
What rules you out
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test...
- Uncontrolled active infection necessitating systemic therapy.
- Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit. Note the following people will be...
- people with a history of hepatitis B but have received antiviral therapy and have nondetectable viral DNA for 6 months prior to enrollment are eligible
- people seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are eligible
- people who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible
- If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.
- Concurrent use of systemic glucocorticoids in greater than replacement doses (unless as a part of a standard of care salvage therapy or conditioning protocol), or steroid dependency defined in rheumatological and...
- Hydrocortisone 25mg/day or less
- Prednisone 10mg/day or less
- Dexamethasone 4mg or less Note: Recent or current use of inhaled glucocorticoids is not exclusionary, as this route pertains extremely minimal systemic penetration.
- Any uncontrolled active medical disorder that would preclude participation as outlined in the opinion of the treating investigator and/or study chair
- HIV infection.
- people declining to consent for treatment
- people who have received or will receive live vaccines within 30 days before the first experimental cell treatment. Inactivated seasonal flu vaccination is allowed.
- people with active autoimmune diseases who need systematic treatments (such as disease modifying agents, corticosteroids and immunosuppressive drugs) in the last 2 years. Note: Replacement therapy (thyroxine, insulin or...
- people with a history of mental disorders or drug abuse that may influence treatment compliance.
- Active malignancy not related to a T-cell malignancy that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or...
- Treatment with any investigational cell/gene therapy within the past 6 months
- Treatment with any investigational anticancer agent within 14 days of study entry or 5 half-lives (whichever is shorter) Eligibility for Conditioning Chemotherapy
- Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values.
- Review of co-morbidities to confirm no major changes in health status (examples of major changes include heart attack, stroke, and any major trauma).
- Planned infusion dose was successfully manufactured and met release criteria.
- Negative pregnancy testing (if applicable). Eligibility for CD4CAR infusion: Inclusion
- Afebrile and not receiving antipyretics, and no evidence of active infection.
- Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values. The following test does not need repeated: EF if obtained within 6 weeks of initial assessment.
- If previous history of corticosteroid chemotherapy, subject must be off all but adrenal replacement doses 3 days before the CD4CAR infusion. Exclusion Note: A subject may still receive the CD4CAR infusion up to 10 days...
- Requirement for supplemental oxygen to keep saturation greater than 95% or presence of radiographic abnormalities on a clinically indicated chest x-ray that are progressive.
- New cardiac arrhythmia not controlled with medical management.
- Hypotension requiring pressor support.
- Positive blood cultures for bacteria, fungus, or virus within 48-hours of T cell infusion. Contraception and Reproductive Potential Guidelines Female people of reproductive potential (women who have reached menarche or...
- Condoms (male or female) with or without a spermicidal agent.
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormonal-based contraception people who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral...
- Physician report/letter
- Operative report or other source documentation in the subject record (a laboratory report of azoospermia is required to document successful vasectomy)
- Discharge summary
- Laboratory report of azoospermia
- Follicle stimulating hormone measurement elevated into the menopausal range
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Indianapolis, Indiana, United States; New York, New York, United States; Stony Brook, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.