Recruiting PHASE2 Peripheral T Cell Lymphoma

New treatment option for Peripheral T Cell Lymphoma

Official title CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

ClinicalTrials.gov ID: NCT04083495

What this study is testing

What is ATLCAR.CD30 T cells?

ATLCAR.CD30 T cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for peripheral 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 is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated.

Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 99

You may be able to join if

for the Study
Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject or...
Age ≥ 18 years at the time of consent.
Karnofsky score of \>60%
Histological or cytological evidence/confirmation of CD30+ peripheral T-cell lymphoma per the 2017 World Health Organization Classification of...

You likely can't join if

for the Study
Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study ).
Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at...
Active infection with HIV, HTLV, HCV (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection...
people who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active...
Informed consent to undergo cell procurement understood by and signed by the subject or legally authorized representative; subject and/or legally...

See the full eligibility criteria

Who can join

for the Study
Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.
Age ≥ 18 years at the time of consent.
Karnofsky score of \>60%
Histological or cytological evidence/confirmation of CD30+ peripheral T-cell lymphoma per the 2017 World Health Organization Classification of Haematopoietic and Lymphoid Tissues.
CD30+ disease determined via archival tissue after the subject's most recent anti-CD30 therapy prior to ATLCAR.CD30 (result can be pending at the time of cell procurement but must be confirmed prior to treatment with...
Any people who has received at least two prior lines of therapy for their lymphoma. If transplant is given as a preplanned consolidation in first remission, it will not be counted as a second line of therapy.
Any subject who has received one line of therapy who has primary refractory lymphoma or lymphoma that relapsed within 12 months of completing chemotherapy or receiving transplant as long as prior therapy included...
people relapsed after autologous stem cell transplant are eligible for this study.
people relapsed after allogeneic stem cell transplantation are eligible provided the patient is ≥180 days from transplant, not on immunosuppresive therapy to treat/prevent graft-versus-host disease and has no evidence...
people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
Female people of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. Note: Females are considered of childbearing potential unless they are surgically sterile...
Female people of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study...
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

What rules you out

for the Study
Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study ).
Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed.
Active infection with HIV, HTLV, HCV (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility...
people who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded...
Informed consent to undergo cell procurement understood by and signed by the subject or legally authorized representative; subject and/or legally authorized representative given a copy of informed consent form for cell...
Subject has life expectancy ≥ 6 weeks.
Subject has evidence of adequate organ function within 7 days of procurement as defined by:
Hemoglobin ≥8.0 g/dL (transfusion is allowed prior to procurement)
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's Syndrome
AST ≤ 3 × ULN
ALT \< 3 x ULN
Creatinine ≤ 2 × ULN
Pulse oximetry of \>90% on room air
Imaging results from within 90 days prior to procurement to assess presence of active disease.
Negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for \>1 year, or...
Written informed consent explained to, understood by and signed by the subject or legally authorized representative; subject and/or legally authorized representative given a copy of informed consent form.
Imaging results from within 10 days prior to lymphodepletion. Imaging must occur at least 3 weeks after most recent therapy (used as baseline measure for documentation of progression before the lymphodepletion) to...
Subject must demonstrate adequate organ function prior to lymphodepletion as defined below. All tests must be obtained within 72 hours prior to lymphodepletion:
Absolute neutrophil count ≥ 1.0 × 10\^9/L
Platelet count ≥ 50 × 10\^9/L
Total bilirubin \< 2 x ULN unless attributed to Gilbert's syndrome
AST ≤ 5 x ULN
ALT ≤ 5 x ULN
Creatinine ≤ 3 x ULN
Pulse Oximetry of \>90% on room air
Subject must have available autologous transduced activated T cells product at a dose of 2x10\^8 cells/m\^2 and meets the Certificate of Analysis acceptance criteria.
No major surgery within 28 days prior to lymphodepletion.
Negative serum pregnancy test within 72 hours prior to lymphodepleting therapy for female participants of childbearing potential. Note: Females are considered of childbearing potential unless they are surgically sterile...
Subject has not received any investigational agents or any tumor vaccines within the previous six weeks prior to lymphodepletion.
Subject has not received anti-CD30 antibody-based therapy within the previous 4 weeks prior to lymphodepletion.
Subject has not received chemotherapy within the previous 3 weeks prior to lymphodepletion.
Subject does not have rapidly progressive disease, per treating oncologist's discretion.
Subject is a good candidate for CAR T cell therapy, per treating oncologist's discretion.
people on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See...
Subject is not taking a prohibited or contraindicated medication prior to lymphodepletion.
Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. Eligibility Criteria...
Subject has no evidence of uncontrolled infection or sepsis.
Negative serum pregnancy within 7 days of cell product administration for females of childbearing potential (does not need to be repeated if pre-lymphodepletion pregnancy test is within window). Note: Females are...
Evidence of adequate organ function as defined by:
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air
Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator.
Subject is a good candidate for treatment with ATLCAR.CD30 cell product per the clinical investigator's discretion. Eligibility Criteria Prior to Lymphodepletion #2
Imaging results from within 21 days prior to lymphodepletion to confirm that the subject has derived clinical benefit from the initial infusion as assessed by the investigator. Clinical benefit will be defined as:
Subject with stable disease or better after the first ATLCAR.CD30 infusion without subsequent progressive disease.
people that had a PR or CR and progressed after the first ATLCAR 30 infusion and prior to second lymphodepletion. A second infusion will be made available to the subject, if the subject chooses, if the treating...
people who experienced Grade 4 CRS or Grade 4 ICANS as a result of the initial ATLCAR.CD30 infusion are only eligible for a second round of lymphodepletion and infusion if they have partial response or better to the...
Subject must demonstrate adequate organ function prior to lymphodepletion as defined below. All tests must be obtained within 24 hours prior to lymphodepletion:
Absolute neutrophil count ≥ 1.0 × 10\^9/L
Platelet count ≥ 50 × 10\^9/L
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air
Subject must have available autologous transduced activated T cells product at a dose of 2x10\^8 cells/m\^2 and meets the Certificate of Analysis acceptance criteria.
Negative serum pregnancy test within 72 hours prior to lymphodepleting therapy for female participants of childbearing potential. Note: Females are considered of childbearing potential unless they are surgically sterile...
Subject does not have evidence of uncontrolled infection or sepsis.
Subject is not receiving a prohibited medication at time of starting lymphodepletion up through 72 hours after the last dose of cyclophosphamide.
Subject is a good candidate for CAR T cell therapy, per treating oncologist's discretion.
Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. Eligibility Criteria...
Subject has no evidence of uncontrolled infection or sepsis.
Negative serum pregnancy within 7 days of cell product administration for females of childbearing potential (does not need to be repeated if pre-lymphodepletion pregnancy test is within window). Note: Females are...
Evidence of adequate organ function as defined by:
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air
Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator.
Subject is a good candidate for treatment with ATLCAR.CD30 cell product per the clinical investigator's discretion.

The study team makes the final eligibility decision.

Where it's taking place

Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, 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, 18 years to 99 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chapel Hill, North Carolina, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.

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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.