Clinical trial · Interventional
CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia
Phase I, Open Label, Multicenter, Dose Escalation and Expansion Study of IMJ995 in Acute Lymphoblastic Leukemia
NCT05168748CI-TRIAL-00062817withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMJ995 single agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMJ995 in ALL
- description
- Dose escalation and expansion of IMJ995 single agent in ALL
- interventionNames
- Drug: IMJ995 single agent
Primary outcomes (3)
- measure
- Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only, in pediatric, adolescent and young adult ALL patients)
- timeFrame
- 28 days
- description
- Dose recommendation for IMJ995 in pediatric, adolescent and young adult ALL patients
- measure
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (pediatric, adolescent and young adult ALL patients)
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: All patients: * Evidence of CD19 and/or CD22 cell surface expression on B-ALL blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry. Pediatric, adolescent and young adult ALL patients: * 1 - 29 years of age at the time of informed consent form (ICF) signature. * Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT. * Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression occurred or have not been eligible for CD19 directed CAR-T treatment. * Lansky (age \< 16 years), Karnofsky (age 16-25 years) performance status ≥ 60%. ECOG (age \>25 years) performance status that is either 0 or 1 at screening. Adult ALL patients aged ≥30 years: * ≥30 years of age at the time of informed consent form (ICF) signature. * Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following: * After allogeneic HCT * After 2 or more lines of treatment, including blinatumomab and/or inotuzumab * Primary refractory disease (defined as failure to achieve a CR at the end of at least 1 induction chemotherapy) * First relapse occurring within 12 months from first remission * ECOG performance status that is either 0 or 1 at screening. Exclusion Criteria: * Allogeneic HCT within 12 weeks prior to screening. * Presence of isolated extra-medullary disease, testicular involvement or bulky disease * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome. * Patients with Burkitt's lymphoma/leukemia * History of active neurological auto immune or inflammatory disorders Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.