Clinical trial · Interventional
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients. The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Multiple Myeloma, Refractory | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TEG002 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm, Open label
- description
- This is a single arm, open-label, multicenter phase I study with a dose escalation and an expansion segment. For the Dose escalation segment, 3-9 patients per dose cohort will receive: * Dose level 1: Low * Dose level 2: Medium * Dose level 3: High For the expansion segment, additional patients may be enrolled until a maximum of 20 patients have received the recommended dose
- interventionNames
- Biological: TEG002
Primary outcomes (2)
- measure
- Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
- timeFrame
- Until day 28 following infusion
- description
- For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
- measure
- Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Adult * Relapsed or refractory Multiple Myeloma as defined by the IMWG * Life expectancy ≥3 months * ECOG performance status 0 or 1 * Adequate vital organ function * Adequate bone marrow function * Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline * WCBP and men who can father children must be willing and able to use adequate contraception Exclusion Criteria: * Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined * Pregnant or lactating women * Amyloidosis * Uncontrolled infection(s) * Active CNS disease * Previous allogeneic-HSCT * History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. * Subjects that received experimental or systemic therapy \< 14 days before TEG002 infusion * NYHA Class ≥ II * Patients depending on dialysis * Patients with a history of pulmonary embolism or deep vein thrombosis * T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy
References
Publications (0)
Data not yet available