Retreatment With CTL019/CTL119
ConditionLymphoma, B-Cell
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to < 2 year survival) with currently available therapies.
Disqualifiers
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Any uncontrolled active medical disorder that would preclude participation as outlined.
Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
Trial design
Design model
Single group
Treatments tested in this trial
CD19 redirected autologous T cells (CTL019 or CTL119 cells)
DrugRetreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Retreatment with CTL019/CTL119Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety of retreatment with CTL019/CTL119 as measured by treatment-related events
Time frame
At time of consent through 1 year after the subject received CTL019/CTL119Secondary outcomes
1
Overall response rate using Cheson 2007 criteria
Efficacy of retreatment with CTL019/CTL119 as measured by ORR by Cheson 2007 definitions at 3 months
Time frame
Month 3 post-infusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: