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Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia (CALM)
Servier Protocol Code:
CL1-68587-002
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02746952
EudraCT Number:
2016-000296-24
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 9 locations
Study description
This study was done to test a new anticancer drug called UCART19 (also called S68587) in patients with leukaemia. Leukaemia is a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made).
UCART19 is made of specially modified cells, designed to kill leukaemia cells. It is a “cell-based gene therapy”.
The main objectives of this study were:
- To look at the safety of UCART19.
- To find the highest tolerated dose of UCART19. This highest tolerated dose helps to find the “recommended dose” (dose that is both safe and effective for patients).
- To find the best treatment to eliminate white blood cells (called lymphocytes) and prepare the blood to receive UCART19 cells. This is called “lymphodepletion treatment”.
Official title: Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)
Results
English (USA)Conditions
B-cell Acute Lymphoblastic Leukemia
Interventions / Treatments
The treatment(s) given to the participants in the study.
- UCART19
Other study id numbers
Other identification numbers the study may be known by.
- CL1-68587-002
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
16 years to 69 years
(Child, Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part in the study, participants had to:
- Be between 16 and 69 years old.
- Have been diagnosed with a kind of blood cancer called “CD19 positive B-acute lymphoblastic leukaemia”.
- Have leukaemia that came back after standard treatment, or did not respond to the standard treatment.
- Have no other treatment options.
Participants could not take part in the study if they:
- Had treatment with radiation within 8 weeks before starting the study.
- Had another cancer within the two years before starting the study.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Single Group
A single group study design involves studying one group of participants who all receive the same treatment. Researchers observe the group's results to understand the effects of the treatment.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
UCART19
All patients received the same study drug, called UCART19: 3 increasing dose levels were tested (DL1, DL2 and DL3). Each patient received a single dose of UCART19 by intravenous (into a vein)
Intervention / Treatment
The treatment(s) given to the participants in the study.
Biological:
UCART19
Keywords
Additional Relevant MeSH Terms Glioma
Burkitt Lymphoma