Clinical trial · Interventional
Treated T Cells Followed by a Stem Cell Transplant in Treating Patients With Multiple Myeloma
Induction of Anti-Myeloma Stem Cell Immunity With Infusions of Autologous Activated T Cells Armed With OKT3 x Rituxan (Anti-CD3 x Anti-CD20) Bispecific Antibody (CD20Bi) (Phase I).
- 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)
RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase I trial is studying the side effects and best way to give treated T cells followed by stem cell transplant in treating patients with multiple myeloma.
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 |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells | Biological | — | UNRESOLVED |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Armed-activated T cells/Immunotherapy
- description
- At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
- interventionNames
- Biological: anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (2)
- measure
- Cell-based toxicities according to NCI CTCAE v3.0 criteria
- timeFrame
- Up to week 4 after chemotherapy
- measure
- Ability to mobilize the number of stem cells required for autologous peripheral blood stem cell transplantation (PBSCT)
- timeFrame
- By day 30 after autologous stem cell transplant (ASCT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Candidate for high-dose chemotherapy and autologous stem cell transplantation * No definite morphologic evidence of myelodysplasia on pretreatment bone marrow PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 70-100% * ANC \> 500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Total bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 3 times upper limit of normal * Creatinine ≤ 2.0 mg/dL * LVEF ≥ 45% * Corrected pulmonary diffusion capacity ≥ 50% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infections or other severe medical problems such as adrenal dysfunction * No other active malignancy (except for nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiotherapy * No HIV infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * On-chemotherapy induction with thalidomide or lenalidomide with dexamethasone is allowed * No prior stem cell transplantation * No more than 2 prior treatment regimens (including the one during which patients undergo leukapheresis for T-cells) * No more than 4 courses of lenalidomide in combination with other agents or as a single agent over a 1-year period * No other concurrent immunotherapy, radiotherapy, chemotherapy, or anti-myeloma therapy at the time of the anti-CD3 x anti-CD20-armed ATC infusion
References
Publications (0)
Data not yet available