UCART22 for B-cell Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
B-cell Acute Lymphoblastic LeukemiaUCART22 - Biological
Eligibility
15 - 70
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new treatment for leukemia, UCART22, to see if it is safe and effective. They will be giving it to patients intravenously and will be monitoring for side effects and how well it works.

Eligible Conditions
  • B-cell Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: 24 Months

24 Months
For Dose Expansion: confirmation of the RP2D in patients with R/R B-ALL who have failed a CD19 directed therapy
Incidence of AE/SAE/DLT [Safety and Tolerability)
Incidence of AE/SAE/DLT [Safety and Tolerability]
Month 24
Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)
Response Assessment determined using the response criteria as defined in NCCN guidelines version 1.2020 for Acute Lymphoblastic Leukemia
Month 24
Duration of Response
Month 24
Overall Survival
Month 24
Progression Free Survival
Lymphodepletion to Day 56
Pyruvate Kinase
Up to D28 post initial UCART22 infusion
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Alemtuzumab
13%Hypothyroidism
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01395316) in the Alemtuzumab ARM group. Side effects include: Hypothyroidism with 13%.

Trial Design

1 Treatment Group

Dose Escalation
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: UCART22 · No Placebo Group · Phase 1

Dose EscalationExperimental Group · 2 Interventions: CLLS52, UCART22 · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Cellectis S.A.Lead Sponsor
5 Previous Clinical Trials
164 Total Patients Enrolled
Nitin Jain, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
1,647 Total Patients Enrolled

Eligibility Criteria

Age 15 - 70 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with acute lymphoblastic leukemia.